Epi proColon

Epi proColon http://www.epiprocolon.com/ Epi proColon Newsfeed de, en Epi proColon http://www.epiprocolon.com/typo3conf/ext/tt_news/ext_icon.gif http://www.epiprocolon.com/ 18 16 Epi proColon Newsfeed TYPO3 - get.content.right http://blogs.law.harvard.edu/tech/rss Wed, 15 May 2013 09:00:00 +0200 Results of Comparative Study between Epigenomics Epi proColon® and FIT to be Presented at Digestive Disease Week http://www.epiprocolon.com/forum/nachrichten/article/ergebnisse-der-vergleichsstudie-zwischen-epigenomics-epi-procolonR-und-fit-werden-auf-der-digestive.html Berlin, Germany, and U.S.A., - Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American... ® and fecal immunochemical testing (FIT) will be presented at a workshop of the WEO (World Endoscopy Organization) Colorectal Cancer Screening Committee during this year’s DDW (Digestive Disease Week) Conference in Orlando, FL, U.S.A., on May 17, 2013.

Epi proColon^® demonstrates 74% sensitivity in CRC detection and is non-inferior to FIT
Blood-based test has potential to increase patient acceptance in CRC screening according to Prof. David Johnson

The results will be presented by Nicholas Potter, Ph.D., Molecular Pathology Laboratory Network, Inc. Maryville, TN, U.S.A., on behalf of the authors, including lead author David A. Johnson, Gastroenterology Division, Eastern VA Medical School, Norfolk, VA, U.S.A., one of the leading gastroenterologists in the US and co-author of several CRC screening guidelines including those of the US Multisociety Task Force and the American College of Gastroenterology.

In the final analysis of the study results, it was demonstrated that Epi proColon^® was able to detect 74% of all evaluable CRC cases in this large multi-centric clinical study, in comparison to 67% of CRC cases detected by FIT. Nicholas Potter concluded that it was demonstrated that sensitivity of the plasma-based methylated Septin9 test is statistically non-inferior to a widely recommended stool-based screening test (FIT).

Analysis of Septin9 DNA methylation in plasma represents a straightforward, minimally invasive method to detect all stages of CRC which either alone or in combination with other screening strategies has the potential to satisfy unmet needs for increased compliance in the screening population. Prof. Johnson commented: “This technology introduces a new opportunity to increase patient acceptance and compliance with CRC screening. Anything that increases screening should be viewed as a favorable advance in the goal to decrease CRC mortality.“

Dr. Uwe Staub, Chief Operating Officer of Epigenomics, commented: “We are very pleased with the final study results, which have now been under review by the FDA since earlier this year. Participation in CRC screening programs and acceptance of recommended methods, including non-invasive stool-based tests, are still too low. Based on the achieved non-inferiority in CRC detection, we believe that Epi proColon^® has the potential to significantly drive awareness and acceptance for CRC screening among those who would otherwise be non-compliant.”

WEO Colorectal Cancer Screening Committee Meeting, DDW Workshop 2013:

The presentation titled “Use of FIT versus Septin 9: Trial results” presented by Nicholas T. Potter will be held at the WEO (World Endoscopy Organization) Colorectal Cancer Screening Committee Meeting, DDW 2013 Workshop, in Orlando, FL, U.S.A. on Friday, May 17, 2013 during the session “Updates on Screening Methods/ New Tests” which is scheduled for 3.30 pm to 5.10 pm.

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Contact Epigenomics AG

Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Präsidentenstrasse 1
10178 Berlin
Tel. +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

For US press inquiries:

Epigenomics, Inc.
9700 Great Seneca Highway Rockville
Maryland 20850
pr@epigenomics.com

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon^®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies and testing laboratories. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> 2013 Epi proColon Company Wed, 15 May 2013 09:00:00 +0200 Epigenomics signs licensing agreement with BioChain for Septin9 in China http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-unterzeichnet-lizenzvereinbarung-mit-biochain-fuer-septin9-in-china.html Berlin, Germany, Seattle, WA, and San Francisco, CA, U.S.A., Beijing, China - Epigenomics AG...
Grace Tian, Chief Executive Officer of BioChain Institute, Inc., U.S.A., noted: “Through this agreement we will immediately initiate efforts in China to validate and deploy the methylated Septin9 assay allowing the establishment of new standards for access and convenience in our home market. We see this effort as a first step in developing a relationship with Epigenomics to bring early stage cancer detection to the market.”

Additionally, Dr. Thomas Taapken, Chief Financial Officer and acting Chief Executive Officer of Epigenomics, commented: “We are pleased that BioChain has decided to collaborate with us in making a methylated Septin9 assay available in mainland China. This allows more convenient alternatives for CRC screening to become available in this emerging market, where prevalence of CRC in the population is on the raise and growing awareness is creating a need for early detection.”

– Ends –

Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

About BioChain

BioChain (www.biochain.com, www.biochainbj.com) is a manufacturer of Life Sciences tools and the pioneer of molecular genetics diagnostics in the US and China. It is also the owner and operator of an independent reference laboratory, equivalent of a CLIA lab, in China – Beijing BioChain Medical Laboratory (BBML). BBML is unique in that it focuses on the application of molecular diagnostics technologies and products. BBML is located in the economic development zone of Beijing, China. Through BBML, BioChain is committed to the application of the cutting edge “omics” technologies in the areas of reproductive health and cancer diagnosis.

BBML offers comprehensive services to its customers in China with a list of cellular and molecular test menus based on diverse technologies appropriate to each stage and type of disease. Technology platforms employed by BioChain include karyotyping analysis of cytogenetics, fluorescent in-situ hybridization (FISH), array comparative genomic hybridization (aCGH), quantitative PCR (qPCR), Sanger sequencing, next generation sequencing (NGS), multiplex ligation-dependent probe amplification (MLPA), and genetic linkage analysis. BioChain has a strong bioinformatics team and established the first Chromosomal Health Database for the Chinese population (www.szjkzd.org:8080/app/auth).

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> 2013 Company Epi proColon Thu, 07 Mar 2013 10:00:00 +0100 Epigenomics AG submits the fourth module and completes its PMA submission to the FDA for Epi proColon® http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-reicht-viertes-modul-fuer-epi-procolonR-bei-der-fda-ein-und-schliesst-damit-zulassungsa.html Berlin, Germany, and Seattle, WA, U.S.A. - Epigenomics AG (Frankfurt Prime Standard: ECX), the...
The fourth module of the PMA contained the clinical data generated with the test, including the results of the recently reported head-to-head comparative study of Epi proColon® to FIT, previously announced data from a clinical validation study in a cohort of prospectively collected samples and other clinical study results generated during the development of Epi proColon®.

Thomas Taapken, Chief Financial Officer and acting Chief Executive Officer of Epigenomics commented: "The non-inferiority of Septin9 to FIT demonstrated by the results of the head-to-head comparative study that were announced in December 2012 was a very important milestone for us. We are very pleased that we were able to complete the submission of the PMA to the FDA by year end 2012, meeting our previously announced guidance. We continue to believe that our test is as effective as other non-invasive tests currently used with the added convenience of being a blood test, which will help drive screening compliance and therefore save more lives."

– Ends –

Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.
]]> Epi proColon Company 2013 Mon, 07 Jan 2013 08:30:00 +0100 Epigenomics Provides Additional Data on the Outcome of its Head-to-Head Comparison Study of Epi proColon® to FIT http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-gibt-weitere-daten-zu-den-ergebnissen-der-direkten-vergleichsstudie-zwischen-epi-procolo.html Berlin, Germany, and Seattle, WA, U.S.A., December 19, 2012 - Epigenomics AG (Frankfurt Prime...
The subjects included in the first arm of the study were average risk, asymptomatic screening patients with no history (own or familial) of CRC. These patients were identified as CRC patients in the context of screening colonoscopies performed from April-November 2012 across 70 sites in the US.

As previously reported, in this study, Epi proColon® was able to detect 73 out of 103 cancer cases, demonstrating an overall sensitivity of 71%. Clinical staging information of the disease was available for 71 of the 103 cases.

Further analysis of the data shows that Epi proColon® was able to demonstrate 61% sensitivity for 23 cases in stages 0 and 1 (FIT 61% sensitivity), 75% for 16 cases in stage 2 (FIT 75% sensitivity), 70% for 20 cases in stage 3 (FIT 85% sensitivity) and 92% in 12 stage 4 cases (FIT 64% sensitivity). In the 32 cases of unknown clinical staging, the sensitivity was 69% (57% sensitivity for FIT).

The correspondence of the blood and stool based test methods was 62%, whereby Epi proColon® was able to identify 20 cases that could not be identified by FIT, while FIT identified 17 CRC cases, which were not found through Epi proColon®.

The second arm of the study comprised 198 average risk individuals, which were prospectively enrolled (i.e. before colonoscopy). Among these, 3 CRC cases were identified by colonoscopy. Both, Epi proColon® and FIT were able to find 2 out of these three CRC cases. At the same time, of the 24 advanced adenomas included in the second arm, neither method detected a significant number of these. The adenoma detection for Epi proColon®, as shown in previous studies, was low. Surprisingly, the finding was the same for FIT, although it was previously believed to be a distinct advantage of this method.

Overall reported specificities for Epi proColon® and FIT were at 81% and 98% respectively. While the point estimate of 81% specificity for Epi proColon® was still above the pre-defined non-inferiority margin, this result was statistically non-significant. The difference in specificity is less vital in the Company’s opinion, as patients will undergo a colonoscopy – the currently recommended screening procedure – as a result of a positive test result. In addition to this it is noteworthy that the Company’s CE marked version of the product, optimized for specificity and launched in Europe earlier this year, has a specificity for CRC detection of 99%. This could open additional possibilities to address the US market in the future.

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Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> 2012 Epi proColon Company Wed, 19 Dec 2012 11:00:00 +0100 Epigenomics AG Reports Non-Inferiority of Blood-based Epi proColon® against Fecal Immunochemical Testing in Detection of Colorectal Cancer in a Head-to-Head Comparative Study http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-blutbasierter-test-epi-procolonR-zeigt-aequivalenz-bei-der-erkennung-von-darmkrebs-zum-i.html Berlin, Germany, and Seattle, WA, U.S.A. - Epigenomics AG (Frankfurt Prime Standard: ECX), the... ® and fecal immunochemical testing (FIT) to demonstrate the non-inferiority of Epi proColon^® in detection of CRC. Dr. Thomas Taapken, Chief Financial Officer and acting Chief Executive Officer of Epigenomics, commented: “Based on the achieved non-inferiority in CRC detection, we believe that Epi proColon^® has demonstrated its value to be a convenient non-invasive test alternative for CRC detection. Bringing a blood-based non-invasive product like Epi proColon^® to the market will significantly drive awareness for colorectal cancer screening among individuals that would otherwise be noncompliant, since current compliance to FIT testing remains at low levels.” In the reported trial, Epi proColon^® detected 73 in a total of 103 evaluable samples from patients with colorectal cancer, which represents a sensitivity of 71%. The FIT comparator used in the study, one of the most commonly used FIT products in the US market, detected 66 out of 98 cancer cases for which stool samples were provided, translating into a sensitivity of 67%. Based on Epigenomics’ analysis of the data, which was confirmed by an external party, the Company met the critically important endpoint of non-inferiority with respect to sensitivity of Epi proColon^® to FIT. These results represent an important milestone for Epigenomics and will be part of the final module of the Premarket Approval (PMA) submission expected to be filed with the U.S. Food and Drug Administration (FDA) before the end of this year. The double blind study was performed at 70 clinical trial sites across the US and comprised two arms. The first arm included a total of 103 asymptomatic, average risk individuals without family history or previous incidences of CRC, who were diagnosed and confirmed as having colorectal cancer during a screening colonoscopy. Matched blood and stool samples from these patients were collected at least 10 days after colonoscopy but before surgical intervention. The second arm of the study included 198 individuals selected according to the same criteria, but whose blood and stool samples were collected before the colonoscopy. This study arm included three cancer cases as well as advanced adenomas, polyps and individuals with no evidence of disease. Based on all non-CRC samples from the second arm, specificity for Epi proColon^® was determined at 81% and for FIT at 98%. These findings are in line both with previous studies on Epi proColon® and published data for FIT. In summary, Epigenomics met the critically important sensitivity endpoint, which provides the potential to discover more CRC patients. The difference in specificity was anticipated and in the Company’s opinion is less vital, since patients will undergo a colonoscopy –the currently recommended screening procedure– as a result of a positive test result. Testing of all samples was performed strictly according to the instructions for use by the respective manufacturers of both tests at an independent third party testing laboratory in the US, which was blinded to the samples analyzed. Dr. Uwe Staub, Chief Operating Officer of Epigenomics, commented: “These positive study results confirm the performance of our assay and indicate that Epi proColon^® is non-inferior to FIT in the detection of CRC. We look forward to an active dialogue with the agency upon completion of our PMA filing before the end of this year.” The company plans to submit detailed study results for presentation at a medical meeting and for peer-reviewed publications in the near future. Conference call for press and analysts Epigenomics’ management will host a conference call and an audio webcast at 5pm CET/11am ET today, Tuesday 4th December 2012.

The dial-in numbers for the conference call are:

Dial-in number (within Germany): + 49 69 247501899

Dial-in number (within the UK): + 44 203 1474861

Dial-in number (within the U.S.): + 1 212 4440297

Participants are kindly requested to dial in 10 minutes prior to the start of the call.

The presentation accompanying the conference call and dial-in details for the audio webcast will be available on Epigenomics’ website:
http://www.epigenomics.com/en/news-investors.html

A webcast of the conference call will be provided on Epigenomics’ website subsequently: http://www.epigenomics.com/en/news-investors.html - Ends – Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon^®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> 2012 Company Epi proColon Tue, 04 Dec 2012 14:15:00 +0100 Epigenomics AG to Provide an Update on the Septin9 Program During a Corporate Workshop on Colorectal Cancer Screening at the Association of Molecular Pathology (AMP) 2012 Annual Meeting http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-gibt-ein-update-ueber-sein-septin9-programm-im-rahmen-eines-workshops-zum-thema-darmkr.html Partners Quest Diagnostics and ARUP Laboratories to discuss experiences with laboratory developed...
The workshop will include a presentation of the results from the pivotal trial with Epigenomics’ colorectal cancer blood test, Epi proColon®, for US pre-market approval, as well as discussions on the individual experiences and perspectives of various groups using the Septin9 biomarker. Presentations will be made by:

Nicholas Potter, Ph.D., FACMG, Chief Scientific Officer and Director of Molecular Diagnostics at Molecular Pathology Laboratory Network, Inc., Maryville, TN

“Septin9 in the Molecular Diagnostics Setting: Results of the Epigenomics Pivotal Trial”
Frederic Waldman, MD Ph.D., Medical Director, Cancer Diagnostics, Quest Diagnostics Nichols Institute, San Juan Capistrano CA

"ColoVantage®, Methylated Septin9: Quest Diagnostics' Experience with its Laboratory-Developed Blood Test for the Colorectal Cancer Genetic Marker After Tens of Thousands of Tests Performed”
Karen Heichman, Ph.D., Adjunct Associate Professor of Pathology at the University of Utah School of Medicine and VP Oncology Technology Development and Licensing of ARUP Laboratories, Inc., Salt Lake City, UT

“ARUP’s Experience with the SEPT9 Blood-based Colorectal Cancer Test”
Professor Dr. Béla Molnár, MD Ph.D., Department of Internal Medicine of Semmelweis University in Budapest, Hungary

“Update on Septin9 Research”

Karen Heichman, Ph.D., Adjunct Associate Professor of Pathology at the University of Utah School of Medicine and VP Oncology Technology Development and Licensing of ARUP said: “ARUP continues to see steady volumes of our Septin9 colorectal cancer test. Based on our collaborative research demonstrating strong patient preference for blood-based testing, it is clear that as physicians and patients become informed, molecular tests such as Septin9 will play an increasing role in patient care."

“We are extremely pleased to have this year’s lineup of speakers and contributors at our workshop,” said Noel Doheny, CEO of Epigenomics’ US Subsidiary. “AMP represents an important opportunity to inform the medical community of the work that we and our partners are doing using Septin9 testing.”

Dr. Thomas Taapken, CEO/CFO of Epigenomics AG remarked that “Epigenomics is highly anticipating the results of its Septin9 biomarker-based test, Epi proColon®, compared directly to the fecal immunochemical test (FIT). The results of the comparison study will be included in the pre-market application for the use of Epi proColon® as a colorectal cancer screening test to be submitted to FDA later this year.”

The workshop is designed to update the AMP laboratory community about the growing opportunity for laboratories to help improve participation in colorectal cancer testing. The increasing availability of blood-based molecular diagnostic method allows patients more flexible choices for their routine health care. The addition of these types of assays provides an innovative role for molecular laboratories and builds on their historic molecular testing expertise.

– Ends –

Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> 2012 Company Epi proColon Mon, 22 Oct 2012 15:00:00 +0200 Epigenomics welcomes reimbursement of the Septin9 blood based colorectal cancer test by Swiss Life in France http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-begruesst-erstattung-des-septin9-bluttests-zur-frueherkennung-von-darmkrebs-durch-swiss-lif.html Berlin, Germany, and Seattle, WA, U.S.A., July 05, 2012 - Epigenomics AG (Frankfurt Prime Standard:...
Colorectal cancer remains the third leading cause of cancer-related deaths in France. The disease is curable when detected at the early, localized stage. Crucially, survival rates decrease rapidly once the tumor has spread to vital organs and patients start showing symptoms.

Geert Nygaard, CEO of Epigenomics, said: "We are extremely pleased about the positive reimbursement decision and endorsement of the Septin9 blood based test for CRC detection by Swiss Life France. Our version of the test, Epi proColon® 2.0 CE, has recently become commercially available in France and we look forward to working with healthcare pioneers like Swiss Life to increase compliance to CRC screening in order to improve health outcomes. Furthermore, today’s decision clearly confirms our recently implemented commercialization approach in Europe under which we are working closely with key players in the healthcare system".

"Swiss Life has always paid close attention to medical innovations. This commitment allows us to offer our policyholders access to effective prevention for continuing wellbeing. With 17,000 deaths annually in France and 17 million people eligible to be screened, colorectal cancer is a major public health issue for which Swiss Life has agreed reimbursement of this innovative test," commented Pierre François, CEO of Swiss Life Prévoyance et Santé in France.

Epi proColon® 2.0 CE is the world’s first CE-marked molecular diagnostic test for the early detection of colorectal cancer in blood. The test uses Epigenomics’ proprietary colorectal cancer biomarker Septin9 in blood plasma and has recently become commercially available in France.

– Ends –

Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> 01 Year Press Releases Company Epi proColon 2012 Thu, 05 Jul 2012 08:04:00 +0200 Epigenomics AG announces non-exclusive licensing agreement for Septin9 with Companion Dx Reference Lab http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-gibt-ein-nicht-exklusives-lizenzabkommen-fuer-septin9-mit-companion-dx-reference-lab-b.html Berlin, Germany, and Seattle, WA, U.S.A., June 19, 2012 - Epigenomics AG (Frankfurt Prime Standard:...
“The addition of Septin9 to our offering of cancer related products will allow us to more effectively serve the Texas cancer testing market. Colorectal cancer is the second leading cause of cancer-related deaths in the U.S., and we believe that the blood based method to detect colorectal cancer in the currently non-compliant patient population will improve participation in screening and therefore save more lives in Texas”, said Steve Blum, CEO of Companion Dx. “Based on the growing uptake of the Septin9 assay through our LDT licensees, we are excited to add regionally focused Companion Dx lab to the list of our partners as we recognize their ability to reach incremental sub-populations who should be but are not currently screened according to guidelines”, said Noel Doheny, Chief Executive Officer of Epigenomics’ US subsidiary. “Companion Dx shares our objective of providing tests that will help physicians to improve the health outcomes for patients through accurate detection of colorectal cancer and to potentially decrease the rising costs associated with colorectal cancer in the U.S. With today’s licensing agreement, we continue to execute on our commercialization strategy, well ahead of the launch of a proprietary diagnostic product approved by the FDA”, explained Mr. Doheny. The agreement with Companion Dx complements Epigenomics’ LDT agreements with Quest Diagnostics, ARUP Laboratories and Warnex Medical Laboratories in North America. Furthermore, Abbott Molecular has worldwide, non-exclusive license to develop and to commercialize IVD test kit products while Qiagen and Sysmex have acquired options to do so.
– Ends –

Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

About Companion Dx

Companion Dx Reference Lab, LLC is a molecular diagnostic reference laboratory and innovative leader in personalized medicine enabling physicians to tailor medications to their patients based on the individual genetic characteristics. Companion Dx offers a comprehensive list of cutting-edge pharmacogenomic (genetic drug sensitivity) assays and cancer companion diagnostics using state-of-the-art technologies. The company is located in the Biotechnology Commercialization Center at the University of Texas Health Science Center in the Houston Texas Medical Center, the world’s largest medical center. For more information, please visit companiondxlab.com.

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> Company Epi proColon 2012 Tue, 19 Jun 2012 08:48:00 +0200 Epigenomics AG submits the third module in its PMA filing with FDA for Epi proColon® http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-reicht-drittes-modul-des-pma-zulassungsantrags-fuer-epi-procolonR-bei-der-fda-ein.html Berlin, Germany, and Seattle, WA, U.S.A. - Epigenomics AG (Frankfurt Prime Standard: ECX), the... ®.

Module three describes the analytical performance of Epi proColon^®in terms of accuracy, precision and stability. Reproducibility and validation of the analytical performance were assessed through testing at three external laboratories. The first two modules of the PMA are related to design control, manufacturing, quality management, and software validation. The fourth and last module is planned for submission in the second half of 2012 and will include the results of a head-to-head comparative study with the goal of demonstrating non-inferiority of Epi proColon® to fecal immunochemical testing (FIT), which is currently underway and enrolling study subjects according to plan. Furthermore, it will include previously announced data from a clinical validation study in a cohort of prospectively collected samples, and other clinical study results generated during the development of Epi proColon^®.

Under the FDA’s modular PMA submission guidance, the complete contents of a PMA is broken down into well-delineated modules, such as non-clinical, clinical, and manufacturing, that together become a complete application. The FDA reviews each module separately as it is received, allowing companies to receive timely feedback during the review process. The FDA guides that it will take 90 days to complete its review of each module as stated in “Guidance for Industry and FDA staff – Premarket Approval Application Modular Review” as posted on FDA’s homepage.

Geert Nygaard, Chief Executive Officer of Epigenomics commented: "The submission of the third module concludes a significant part of our PMA filing. We look forward to successfully finishing the ongoing clinical trial and subsequently completing our PMA submission to FDA by year end. Our team has been working expeditiously to finalize our first US market application and we remain committed and focused on introducing Epi proColon® as the first FDA approved blood-based test for the early detection of colorectal cancer in the US. We firmly believe that the test will help drive screening compliance and make a difference in detecting cancers in patients who would otherwise avoid being tested for colorectal cancer."

– Ends –

Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon^®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> Epi proColon 2012 Company Tue, 12 Jun 2012 09:00:00 +0200 Epigenomics AG Enrolls First Participant in its FIT comparative study with Epi proColon® http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-schliesst-ersten-patienten-in-seine-fit-vergleichsstudie-mit-epi-procolonR-ein.html Berlin, Germany, and Seattle, WA, U.S.A. - Epigenomics AG (Frankfurt Prime Standard: ECX), the... ® with fecal immunochemical testing (FIT) for colorectal cancer detection. Meanwhile the first study subject has been enrolled.

As previously announced, the US Food and Drug Administration (FDA) has requested Epigenomics to perform a head-to-head comparative study for colorectal cancer detection through comparison with FIT for the purpose of demonstrating non-inferiority of Epi proColon^® to FIT.

Site recruitment and initiation is currently ongoing with the aim of including up to 75 clinical sites. The study will compare FIT and Epi proColon^® analyses for 100 subjects with confirmed cancer (post colonoscopy) and 200 asymptomatic average risk individuals (pre-colonoscopy). Epigenomics plans to complete this study in the second half of 2012 and the results will be an integral part of the company’s Modular Premarket Approval (PMA) submission to the FDA. The company already submitted the first two PMA modules and is on track to file its third and fourth modules in the second quarter and second half of 2012, respectively.

-Ends-

Contact Epigenomics AG

Antje Zeise Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon^®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics’ legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States of America. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S.A. have not been established.]]> 2012 Company Epi proColon Wed, 11 Apr 2012 08:30:00 +0200 Epigenomics AG: Study Shows Patient Preference for Blood Based Colorectal Cancer Screening http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-studie-zeigt-patientenpraeferenz-fuer-blutbasierte-darmkrebs-frueherkennung.html Berlin, Germany, and Seattle, WA, U.S.A. - Epigenomics AG (Frankfurt Prime Standard: ECX), the...
The study assessed the attitudes and preferences of 100 participants eligible for CRC screening of which 44% were previously unscreened, with respect to screening by FOBT, sigmoidoscopy, colonoscopy or Septin9 blood testing. In this focus group study, participants completed a survey after a 90 minute moderated discussion about the procedure, cost and accuracy of all tests.

The survey indicated that given the performance of the ARUP Septin9 test (90% sensitive, 89% specific; Warren et al. 2011) and its cost of approximately USD 180, two thirds of previously unscreened subjects would prefer a Septin9 blood test to other screening methods. Among the positive aspects of the test, participants noted its convenience (62%), cost (52%) and accuracy (55%). Among the negative factors of the test, participants mentioned the inability to detect precancerous polyps (6%) and lack of insurance coverage (6%).

Noel Doheny, CEO of Epigenomics’ US subsidiary and member of the Epigenomics Senior Management Team noted: “The study demonstrates that the convenience of a blood based test should lead to a greater acceptance and thus a higher compliance to colorectal cancer screening. It underlines the value that blood-based Septin9 tests can potentially bring as alternative for the detection of colorectal cancer”.

Karen Heichman, Ph.D., VP Oncology Technology Development & Licensing, ARUP Laboratories added: “ARUP is proud to provide a non-invasive blood based approach that people can use for the early detection of colorectal cancer”.

- Ends -

Further Information

Contact Epigenomics AG Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> 2012 Epi proColon Company Tue, 06 Mar 2012 14:00:00 +0100 Epigenomics Septin9 Biomarker detects Colon Cancer equally in both sides of the Colon http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-biomarker-septin9-findet-darmkrebs-gleich-gut-auf-beiden-seiten-des-kolons.html Berlin, Germany, and Seattle, WA, U.S.A., - Epigenomics AG (Frankfurt Prime Standard: ECX), the...
In a blinded case control study of a total of 184 study participants, plasma from 92 CRC cases (56 left-, 36 right-sided cases) was analyzed and methylated Septin9 was detected in a total of 88 cancer cases, representing 96% sensitivity for overall CRC detection at a specificity of 85%. The control arm consisted of 92 samples of individuals with no evidence of disease as verified by colonoscopy. Sensitivity for detection of left- and right-sided cases was 96% and 94% respectively, thus showing no significant difference between cancer detection in either side of the colon.

In a subset of 39 subjects that received a fecal occult blood test (FOBT, Hemoccult II stool test) in addition to a Septin9 test, the sensitivities for FOBT for the detection of 12 left- sided cases was 83% and 50% for the 10 right-sided cases in this study. Overall, sensitivity for FOBT was 68% and specificity was 71%.

The complete data will be submitted by Prof. Molnár for publication in a peer reviewed journal in due course.

Dr. Jürgen Beck, Senior Vice President of Medical Affairs commented: “These results are in line with previously reported performance evaluations for CRC detection in case control studies performed by Epigenomics and other parties. They reflect the value and the superiority of blood based testing of methylated Septin9 for early detection of colorectal cancer, independently of the localization of the cancerous lesion”

- Ends -

Further Information

Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> 2012 Company Epi proColon Thu, 16 Feb 2012 10:00:00 +0100 Epigenomics AG Completes U.S. Clinical Validation Study for Colorectal Cancer Blood Test Epi proColon; Provides Update on U.S. Regulatory Plans http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-schliesst-klinische-us-validierungsstudie-fuer-darmkrebs-bluttest-epi-procolon-ab-und-g.html Conference Call Scheduled for today, 9thDecember 2011 at 4 pm CET Berlin, Germany, and Seattle,... Conference Call Scheduled for today, 9thDecember 2011 at 4 pm CET Berlin, Germany, and Seattle, WA, U.S.A. Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostic company, today reports the completion of the clinical validation study for its second-generation colorectal cancer blood test Epi proColon in the U.S. The study was designed to measure the clinical performance of Epi proColon for the detection of colorectal cancer in comparison to colonoscopy and is part of the required data package to seek regulatory approval of the product in the U.S. In the reported study, Epi proColon detected 68% of the colorectal cancer cases (sensitivity) while correctly identifying 80% of the patients free of disease (specificity). While the results of the study represent the lower end of the expected performance data, the findings of the study confirm the results obtained in a previously conducted clinical study with the first generation of the company’s Epi proColon test in the same cohort of patients. Study subjects tested were selected from a prospectively collected cohort of 7.940 individuals, defined as being at average risk for colorectal cancer by current screening guidelines and who underwent colonoscopy for colorectal cancer screening. The tested study cohort included 45 cancer cases. All plasma samples selected were blinded, randomized, and tested with Epi proColon at three independent laboratories in the U.S. After consultation with the U.S. Food and Drug Administration (FDA), the company confirmed that the clinical data would be assessed as part of the regular Premarket Approval (PMA) review process. The Company will begin the regulatory process with the FDA by submitting the first module of its PMA this month. In addition to the clinical validation study data, Epigenomics will also perform a head-to-head comparative study for colorectal cancer detection through comparison with fecal immunochemical testing (FIT) for the purpose of demonstrating non-inferiority of Epi proColon to FIT. This study will also become an integral part of the PMA submission to the FDA and is anticipated to be completed in 2012.

Conference Call for Investors and Media

Epigenomics’ management will host a conference call to discuss the study results and to inform about the further process of the FDA submission at 4 pm CET (10 am EST) today, December 9, 2011. The dial-in numbers for the conference call are:

Dial-in number (within Germany):	+49 69 247 501 899
Dial-in number (within U.K.):	+44 203 147 4861
Dial-in number (within the US):	+1 212 444 0297

Participants are kindly requested to dial in 10 minutes prior to the start of the call.

A recording of the conference call will be provided here on our website subsequently.

Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

About Epigenomics

Karen Heichman, Ph.D., Adjunct Assistant Professor of Pathology at the University of Utah School of Medicine and VP Oncology Technology Development and Licensing of ARUP Laboratories, Inc., Salt Lake City, UT,
Brooks Cash, M.D., Gastroenterologist, Bethesda, MD,
Robert Day, M.D., President and Director Emeritus of the Fred Hutchinson Cancer Research Center, Seattle, WA, and
Nicolas Potter, Ph.D., Chief Scientific Officer and Director of Molecular Diagnostics at Molecular Pathology Laboratory Network, Inc., Maryville, TN.

Contact Epigenomics AG

Antje Zeise | CIRO
Manager IR/PR
Epigenomics AG
Tel +49 (0) 30 24345 386
pr@epigenomics.com
www.epigenomics.com

Media inquiries can also be directed at:
Dr. Robert Mayer
Account Manager
Tel +49 (0)89 5238 8030
robert.mayer@collegehill.com

About Epigenomics

Epigenomics is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon^®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> 2011 Company Epi proColon Wed, 16 Nov 2011 10:00:00 +0100 Open letter to the editor of “Clinical Gastroenterology and Hepatology” regarding a recently published article in that journal http://www.epiprocolon.com/forum/nachrichten/article/offener-brief-an-den-herausgeber-von-clinical-gastroenterology-and-hepatology-bezueglich-eines-kuerz.html Open Letter to the Editor C. Mel Wilcox, MD, Editor, Clinical Gastroenterology and Hepatology, AGA,...
C. Mel Wilcox, MD, Editor,
Clinical Gastroenterology and Hepatology,
AGA, 4930 Del Ray Avenue, Bethesda, Maryland 20814-3015;
e-mail: cgh@gastro.org;

Referring to: The Stool DNA Test is More Accurate than the Plasma Septin 9 Test in Detecting Colorectal Neoplasia. Clin Gastroenterol Hepatol. 2011 Oct 19. Author(s): Ahlquist DA, Taylor WR, Mahoney DW, Zou H, Domanico M, Thibodeau SN, Boardman LA, Berger BM, Lidgard GP. Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester MN.

Sir,

In the referenced article, a plasma-test for methylated Septin9 is compared to a stool DNA test, with results inconsistent with those previously reported for the ARUP Septin9 LDT . We developed and licensed the Septin9 technology to ARUP Laboratories and the results reported in the article are inconsistent with our experience of the Septin9 biomarker as well. Careful review of study methodology indicates systemic flaws in the reporting, including missing information and incomplete authorship with a bias potentially originating from the first author’s financial interest in the success of the stool DNA test.

An explanation of the selection process for CRC cases tested in the study is lacking and is described as “selected if they had participated in a recent multicenter evaluation of a prototype next generation sDNA test”. A selection process rather than a more unbiased design of testing all subjects with both tests indicates that bias could have been introduced particularly if a inordinate number of sDNA test positive subjects were chosen. The use of a different set of colonoscopy normal control patients for each test makes any comparison illusive. The choice of the controls for the blood test seems to be inadequate, with both the unusually high false positive rate and the occurrence of 8% (4/49) other cancers in the plasma control group casting doubt whether they represent average risk individuals.

The study employed archived samples although little information is provided on sampling procedures, blood collection tubes used or timing of blood collection – all of which have a significant impact on Septin9 performance. The authors conceded that plasma sample preparation was only “similar” to the test commercialized by ARUP Laboratories. An accurate comparison can only be achieved when both tests have been performed according to procedures that would occur in routine clinical practice. Finally, it seems telling that no co-author from ARUP has been involved in manuscript preparation. This incomplete authorship further supports the grave concern that the article presents a methodologically flawed and biased study. We have knowledge of a letter dated April 15th, 2011 and addressed by ARUP to the first author objecting to a publication. In this letter, an ARUP co-investigator of the study formally raised concerns on the validity of the data.

In summary, the lack of complete protocol information, the lack of a shared set of colonoscopy-normal controls, the nebulous clinical history of the plasma control patients and the incomplete study authorship casts serious doubts about this study as a sincere, scientific comparison between Dr Ahlquist’s stool DNA test and a Septin9 plasma test.

Sincerely yours,

Dr. med. Jürgen Beck Shannon Payne, Ph.D
Senior Vice President Medical Affairs Medical Science Liaison

Epigenomics AG | Kleine Praesidentenstr. 1 | 10178 Berlin, Germany and Epigenomics, Inc. | 901 Fifth Ave, Ste 3800 | Seattle, WA 98164-2044, USA]]> Company Epi proColon 2011 Mon, 07 Nov 2011 09:49:00 +0100 Epigenomics announces the European launch of Epi <i>pro</i>Colon® 2.0 CE http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-kuendigt-markteinfuehrung-von-epi-procolonR-20-ce-in-europa-an.html Presentation of the powerful second generation blood test for colorectal cancer screening during... Presentation of the powerful second generation blood test for colorectal cancer screening during UEGW in Stockholm Berlin, Germany, and Stockholm, Sweden Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostics company, today announced the upcoming launch of Epi proColon^® 2.0 CE in Europe during the United European Gastroenterology Week (UEGW) in Stockholm, Sweden. Epi proColon^® 2.0 CE is the Company’s second generation blood-based test for the early detection of colorectal cancer. The rollout of the new test is expected to start in the near future in Europe and other selected regions through Epigenomics and its network of distributors. The announcement of the launch follows a thorough clinical validation in which the convenient blood test, optimized for maximum specificity for colorectal cancer, demonstrated an accuracy of detecting colorectal cancer that is unmatched by any other non-invasive method of colorectal cancer detection. In particular, the positive predictive value (PPV) of the test – a commonly used measure for the likelihood of actually having cancer when a test is positive – was found to be 45% in a large study evaluating its performance when compared to the PPV of only 10% reported for the most widely used stool tests for colorectal cancer (CRC) screening. To specifically meet market requirements in many European countries, the new product minimizes the number of false positive results while maintaining excellent sensitivity in CRC detection. Thus, Epi proColon^® 2.0 CE detects more than 80% of all colorectal cancers at 99% specificity. With this high level of performance, the new test provides a reliable and convenient alternative to conventional methods of colorectal cancer screening such as stool tests. Geert Nygaard, Chief Executive Officer of Epigenomics commented: “The combination of both high sensitivity and an almost perfect specificity in a single convenient and patient-friendly blood test is what sets Epi proColon^® 2.0 CE apart from currently available in vitro diagnostic tests for colorectal cancer early detection. This test provides a compelling alternative for non-invasive colorectal cancer screening and has an unmatched potential to find acceptance among patients, doctors, and payers.” Epi proColon^® 2.0 CE not only has a significantly enhanced performance over the first generation Epi proColon^® test, but it also features a number of other improvements that should facilitate its use for the diagnostic routine, including fewer reagents and handling steps and a shorter time to results. The test is optimized for the commonly used Roche LightCycler^® 480 and the Applied Biosystems^® 7500 Fast real-time PCR systems. The new Epi proColon^® 2.0 CE test can also be optimized for high sensitivity to colorectal cancer. The Company previously announced data from clinical validation of the blood test using an algorithm optimized for high sensitivity, in which the test demonstrated a sensitivity of 95% and a specificity of 85%. Epigenomics will hold a press briefing at the UEGW, today, Tuesday, October 25, 2011 at 10:35 am CET at booth A13:34 in Hall A, Stockholmsmässan, Mässvägen 1, Älvsjö, 125 80 Stockholm, Sweden. The briefing will include the following presentations:

Dr. Gunter Weiss, Epigenomics’ Vice President Product Development will give an overview on the development and technical improvements of Epi proColon^® 2.0 CE.
Dr. med. Juergen Beck, Senior Vice President Medical Affairs will point out the clinical advantages of the new Epi proColon^® 2.0 CE.
An open discussion afterwards allows enough time for the plenum to ask questions.

Interested parties not present at UEGW can follow the presentations and contribute to the discussion in an audio webcast. The dial-in details for the audio webcast will be available on Epigenomics’ website at http://www.epigenomics.com/en/news-investors.html.

Contact Epigenomics AG

Dr. Achim Plum
Sen. VP Business & Strategy
Epigenomics AG
Tel +49 (0) 30 24345 368
pr@epigenomics.com
www.epigenomics.com

About Epigenomics

Contact Epigenomics AG

Dr. Achim Plum
Sen. VP Business & Strategy
Epigenomics AG
Tel +49 (0) 30 24345 368
pr@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon^®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A. Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> Epi proColon Company 2011 Mon, 19 Sep 2011 10:00:00 +0200 Epigenomics AG: Surveys Show That Patients Believe in Blood Tests for Regular Colorectal Cancer Screening http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-umfragen-zeigen-dass-patienten-auf-bluttests-fuer-regelmaessige-darmkrebs-frueherkennun.html Results of a joint survey by Epigenomics AG and europacolon during the first European Colorectal... Results of a joint survey by Epigenomics AG and europacolon during the first European Colorectal Cancer Patient Conference; nationwide survey in the U.S. reports similar results. Berlin, Germany, and Seattle, WA, U.S.A – Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostics company, today announced the results of a survey conducted at europacolon’s first European CRC Patient Conference, The Power of Patient Voice 2011, showing that patients believe tests using blood samples would encourage more people to participate in regular screening for colorectal cancer. Of the participants in the survey, more than 50 % had previously heard of the possibility of CRC blood testing and more than 70 % thought that using a blood test would encourage more people to participate in regular screening for colorectal cancer. Some of the most often mentioned reasons that survey participants gave for preferring blood tests were ease-of-use and simplicity, not having to handle stool samples as necessary for conventional non-invasive testing, and overall fit with other routine blood tests. The survey was jointly conducted by Epigenomics and europacolon, the first European non-profit organization dedicated to colorectal cancer. europacolon’s mission is to prevent deaths from colorectal cancer and improve the quality of life and support for those affected by the disease. Epigenomics has developed the world’s first in vitro diagnostic blood test for the early detection of colorectal cancer known as the Septin9 Test and fully supports europacolon in its fight against colorectal cancer. Jola Gore-Booth, the Founder and CEO of europacolon commented: “We are delighted that over 140 delegates from 27 countries globally attended this first ever Colorectal Cancer Patient Conference. The great success of the Conference has given us enormous encouragement in our work to promote the prevention and early diagnosis of colorectal cancer in all European countries. Putting in place formal population screening programs for all the citizens of Europe is essential for effective prevention of colorectal cancer and for saving thousands of lives. A blood test for the early detection of colorectal cancer could remove some of the hurdles to effective compliance to colorectal cancer screening and be instrumental in reducing mortality from this killer disease.” Independent of the europacolon survey, Quest Diagnostics, one of Epigenomics’ partners in the U.S.A., in June announced, in collaboration with the U.S. non-profit organization Colon Cancer Alliance, the results of a jointly conducted U.S. national telephone survey of more than 1,300 men and women 50 years of age and older. In this survey, 31 % of the participants reported that they had never been screened for CRC. Of the respondents between 60–70 years of age that had previously participated in screening, 33 % stated that they had only been screened once in the past. These results demonstrate widespread lack of adherence to national guidelines in the U.S.A., which recommend regular screening by colonoscopy in combination with other tests for colorectal cancer for all men and women aged 50 and older. When asked about the option of a blood test, 78 % of the participants said that they were likely to take a blood test for colorectal cancer screening and 75 % said they were more likely to get screened more frequently if a blood test was offered to them. The survey results were presented during the Colon Cancer Alliance’s national conference “Family Matters: What You and Your Family Need to Know about Colon Cancer,” which was held June 23–25 in Denver, CO, U.S.A. Dr. Jürgen Beck, M.D., Senior VP Medical Affairs of Epigenomics, commented: “The lack of widespread acceptance and regular utilization of conventional methods for the early detection of colorectal cancer, such as colonoscopy and stool tests, severely limit the potential of screening to reduce mortality from this common cancer. The two surveys in Europe and the U.S.A. clearly show the potential of blood-based screening as an approach to increase compliance. We expect these findings to be substantiated further through studies into patient preferences and screening adherence that are ongoing at clinical centers in the U.S.A. and Europe.” Colorectal cancer is curable in more than 90 % of cases if diagnosed while still localized. Nevertheless, this disease is one of the most frequent causes of cancer-related deaths in the industrialized world due to lack of adherence to current screening recommendations.

Contact Epigenomics AG

Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 368
pr@epigenomics.com
www.epigenomics.com

Further information

For further information on europacolon please visit www.europacolon.com.
The 2011 europacolon Colorectal Cancer Patient Conference "The Power of Patient Voice" was held on June 24–25, 2011 alongside the 13th World Congress on Gastrointestinal Cancers organized by the European Society for Medical Oncology in Barcelona, Spain. For information on the Colon Cancer Alliance please see www.ccalliance.org.
For press releases on the U.S. survey, please visit Quest Diagnostics’ website or the Colon Cancer Alliance website.

About Epigenomics

About europacolon

europacolon is an independent Not for Profit organisation founded in 2005. It is the first European organisation dedicated to colorectal cancer and it aims to unite patients, carers, healthcare professionals, politicians, the media and the public in the fight against the disease. europacolon’s mission is to reduce deaths and improve the quality of life and support for those affected by colorectal cancer in Europe. Its aims and objectives are to:

Prioritise and raise the profile of colorectal cancer
Establish patient advocacy groups
Create a colorectal cancer community
Increase awareness of symptoms and prevention of the disease
Campaign for screening and improved choice of treatments
Encourage the improvement of European standards and equity of care through the development of National Cancer Plans

Since 2005 europacolon has established dedicated colorectal cancer organisations in 27 European countries: 10 Affiliate Members; 8 Associate Members; and 9 pending Members (Austria, Belgium, Bosnia and Herzegovina, Croatia, Cyprus, Czech Republic, France, Finland, Germany, Georgia, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Republic of Macedonia, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, Sweden, and the UK). For more information, please visit www.europacolon.com.

Notes for editors

About Colorectal Cancer

For 2011 the American Cancer Society expects an estimated 140,000 new cases of colorectal cancer to be diagnosed in the United States and almost 50,000 U.S. citizens to die from the disease. The 5-year survival rate is over 90 % if the disease is treated in early stages but diminishes to about 12 % once the cancer has affected other organs. Today, the majority of cancers are still found in advanced stages due to insufficient patient compliance to screening recommendations that leaves half of the population unscreened. Increasing compliance to regular cancer screening in the population aged 50 years and older is considered key to decreasing mortality from this disease.

Septin9 blood tests for CRC

Epigenomics and its partner Abbott already market their respective first generation CE-marked Septin9 tests in Europe, the Middle East, Asia/Pacific and further markets. Epigenomics is in the process of developing a second generation Septin9 assay as a colorectal cancer screening test for the U.S. and European markets. Epigenomics expects to submit this enhanced Septin9 colorectal cancer screening test branded Epi proColon® 2.0 to the FDA for regulatory review before year-end 2011. Under licenses from Epigenomics, Septin9 testing is currently offered in the U.S.A. by Quest Diagnostics (ColoVantage™) and ARUP Laboratories (Methylated Septin9 Test) as laboratory-developed tests aiding in the detection of colorectal cancer. Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> Company Epi proColon 2011 Thu, 07 Jul 2011 10:00:00 +0200 Epigenomics AG: Screening More People for Colorectal Cancer with Septin9 Blood Tests Could Provide Medical Benefit and Be Cost-Effective http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-mehr-darmkrebs-frueherkennung-durch-septin9-bluttests-waere-medizinisch-vorteilhaft-un.html Health economic analysis in favor of Septin9 testing presented by renowned Stanford University... Health economic analysis in favor of Septin9 testing presented by renowned Stanford University researcher at Digestive Disease Week 2011

Patient behavior study underway to demonstrate compliance benefit

Berlin, Germany, and Seattle, WA, USA - Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostics company, reports that Dr. Uri Ladabaum, Associate Professor in the Department of Gastroenterology and Hepatology at the School of Medicine of Stanford University (Redwood City, CA, U.S.A.), has presented the results of a health economic analysis of potential future colorectal cancer screening with Septin9 blood tests at the ongoing Digestive Disease Week 2011 (Ref. 1). Septin9 tests detect cell-free DNA derived from tumors in the colon and rectum in the blood stream by means of a DNA methylation pattern in the SEPT9 gene that is specific for colorectal cancer. The biomarker and detection technologies used in Septin9 testing are proprietary to Epigenomics.

Using a validated Markov model for colorectal cancer screening reflecting U.S. colorectal cancer epidemiology and health care cost structure, Dr. Ladabaum and coworkers compared Septin9 testing to current standard methods of colorectal cancer screening, i.e. fecal occult blood testing (FOBT), fecal immunochemical testing (FIT), sigmoidoscopy and colonoscopy.

Their analysis is based on clinical performance data for Septin9 testing from a prospective trial with over 7,900 average-risk screening guideline-eligible subjects, previously reported at Digestive Disease Week in 2010. In this study, a first generation Septin9 test detected up to 67% of the cancer cases at 88% specificity (Ref. 2).

The analysis demonstrates that at the population level, Septin9 testing yielded the greatest incremental benefit at acceptable costs when it increases the fraction of the population screened. The group concluded that screening for colorectal cancer using Septin9 tests is a medically beneficial and health economically cost-effective strategy when it addresses the currently unscreened population in the U.S.

Patient behavior studies to understand screening barriers in unscreened individuals and the potential impact of a blood test as an alternative option for screening are ongoing at the University of Utah and the Huntsman Cancer Institute in collaboration with ARUP Laboratories, Salt Lake City, UT, U.S.A. First results from focus groups, recently presented by Jennifer Taber, M.S., of the Department of Psychology at the University of Utah at the 2011 Annual Meeting of the American Society of Preventive Oncology, indicated that the majority of the currently unscreened patients would take a Septin9 test for screening. No significant differences with regard to gender, religion, marital status, health care coverage or ethnicity were observed. Going forward, a quantitative survey and a prospective longitudinal clinical study are planned to further investigate the impact of blood tests on patient acceptance of colorectal cancer screening and their potential to increase overall screening compliance (Ref. 3).

Jennifer Taber remarked: “The initial results suggest that community members are interested in Septin9 testing in part because of its high accuracy and the convenient and noninvasive aspects of the procedure. Going forward, we hope to learn whether blood-based tests will increase colorectal cancer screening rates by reducing the currently existing barriers.”

Dr. Philip Schoenfeld, M.D., M.Sc., M.Sc., Associate Professor of Medicine, Division of Gastroenterology at the University of Michigan School of Medicine and member of Epigenomics’ Medical Advisory Board commented on the two studies: "The cost effectiveness and patient behavior studies are important additions to the clinical utility study completed last year for Septin9. These are essential steps to support physician and payer acceptance of Septin9 testing, and its potential to improve patient access to colorectal cancer screening approaches with clear clinical benefit."

Under licenses by Epigenomics, Septin9 testing is currently offered in the U.S. by Quest Diagnostics (ColoVantage™) and ARUP Laboratories (Methylated Septin9 Test) based on laboratory-developed tests aiding in the detection of colorectal cancer. Epigenomics and its partner Abbott already market their respective first generation CE-marked Septin9 tests in Europe, the Middle East, Asia/Pacific and further markets. Epigenomics is in the process of developing a second generation Septin9 assay as a colorectal cancer screening test for the U.S. and European market. Epigenomics expects to submit this enhanced Septin9 test branded Epi proColon® 2.0 to the FDA for regulatory review and pre-market approval as a colorectal cancer screening test before year-end 2011.

Dr. Juergen Beck, M.D., Epigenomics’ Senior Vice President of Medical Affairs commented: “Dr. Ladabaum and his colleagues have undertaken a thorough and stringent analysis. The results of the study confirm our own expectations on the medical benefit and cost-effectiveness of Septin9 testing and are in line with a future positioning as an additional screening option for those people currently reluctant to undergo screening by available conventional methods. Our emphasis in clinical research now lies on demonstrating the required compliance benefit of Septin9 blood tests and we are looking forward to further results of the ongoing study at the University of Utah and the Huntsman Cancer Institute.”
-Ends-

About Colorectal Cancer

For 2011 the American Cancer Society expects an estimated 140,000 new cases of colorectal cancer to be diagnosed in the United States and almost 50,000 U.S. citizens to die from the disease. The 5-year survival rate is over 90% if the disease is treated in early stages but diminishes to about 12% once the cancer has affected other organs. Today, the majority of cancers are still found in advanced stages due to insufficient patient compliance to screening recommendations that leaves 47% of the population unscreened. Increasing compliance to regular cancer screening in the population aged 50 years and older is considered key to decreasing mortality from this disease. (Ref. 4)

References

Ref. 1: Ladabaum, Uri; Allen, John I.; Wandell, Michael; Ramsey, Scott: Screening for Colorectal Cancer with a Blood Test: Projected Effectiveness and Cost-Effectiveness of a Novel Plasma Methylated Septin-9 DNA (mSEPT9) Assay. Oral presentation at Digestive Disease Week 2011, May 7-10 2011, Chicago, IL, U.S.A. (Abstract #220)

Ref. 2: Church et al.: Methylated SEPT9 Gene in Plasma as a Marker for Detection of Occult Colorectal Cancer in a Screening Population. Oral presentation at Digestive Disease Week 2010, May 1-5, 2010, New Orleans, LA, U.S.A. (Abstract #711d)

Ref. 3: Taber, Jennifer M.; Aspinwall, Lisa G.; Heichman, Karen; Kinney, Anita Y.: Blood-based colorectal cancer screening: Eliciting attitudes and determining predictors of interest in a multiethnic sample. Poster presentation at the 35th Annual Meeting of the American Society of Preventive Oncology, March 4-8, 2011, Las Vegas, NV, U.S.A.

Ref. 4: American Cancer Society. Colorectal Cancer Facts & Figures 2011-2013. Atlanta: American Cancer Society, 2011.

Contact Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 368
pr@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon^®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> Company Epi proColon 2011 Mon, 09 May 2011 10:00:00 +0200 Epigenomics AG: Life Technologies to Supply Crucial Components for Second-Generation Colorectal Cancer Blood Test http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-life-technologies-liefert-entscheidende-komponenten-fuer-darmkrebsbluttest-der-zweite.html Berlin, Germany, and Seattle, WA, U.S.A., May 6, 2011 Epigenomics AG (Frankfurt Prime Standard:... Berlin, Germany, and Seattle, WA, U.S.A., May 6, 2011 Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnosis company, today announced the signing of a supply agreement with Life Technologies Corporation, a global provider of innovative life science solutions. As the Original Equipment Manufacturer (OEM) Life Technologies will supply its Dynabeads^® MyOne™ SILANE and buffers for Epigenomics’ Epi proColon^® 2.0 – the company’s second-generation colorectal cancer blood test that is in development for the European and U.S. in vitro diagnostic (IVD) market. Compared to the first generation test system, Epi proColon^® 2.0 requires fewer components and handling steps, and can reach results within eight hours, making it easier to automate on a wide range of IVD automation solutions. A key feature of the new product is the use of Dynabeads^® MyOne™ SILANE, which are monosized, magnetic beads that bind to nucleic acids (NAs, e.g. DNA) in biological samples. By applying a magnetic field, the Dynabeads^®-NA complex can be separated and the NAs concentrated for diagnostic analysis such as the detection of methylated DNA of the SEPT9 gene, the biomarker that is targeted by Epi proColon^® 2.0. Dynabeads^® and associated reagents are manufactured in compliance with the quality management systems ISO 13485:2003 in Life Technologies’ facilities in Oslo, Norway. All modifications to the assay incorporated into Epi proColon^® 2.0 result in significantly improved clinical performance. In a feasibility study that included 97 colorectal cancer cases and 159 colonoscopy-confirmed controls, the detection of cancer cases was improved to a sensitivity of 91% at 87% specificity. In this study, the new assay identified 21 out of 27 Stage I cancer cases (78%) and 25 out of 25 Stage II cancer cases (100%). This is critically important since patients with Stage I and II of colorectal cancer have a combined five-year survival of about 90% and early clinical interventions can significantly improve survival. Stage III and Stage IV cancers were detected at sensitivities of 92% and 100%, respectively. Dr. Uwe Staub, Senior Vice President Product Development at Epigenomics commented: “Securing access to Life Technologies’ magnetic beads and reagents for our second-generation Septin9 test has been very important for the development of Epi proColon^® 2.0. By including these crucial components into our assay along with some other modifications, we were able to significantly improve clinical performance and shorten the overall time to result allowing for testing of higher volumes of samples.” “Life Technologies prides itself in providing sophisticated technology for next-generation molecular diagnostics solutions that can have a major impact on human health and disease,” said Ole Dahlberg, Country Manager Life Technologies Norway. “The supply agreement between our two companies underscores the commitment to develop and launch new diagnostic applications.” Epigenomics is currently transferring the manufacturing of its Epi proColon^® 2.0 assay to its contract manufacturer NextPharma based in San Diego, CA, U.S.A. Epigenomics plans to conduct analytical and clinical validation studies in the second half of 2011. The company expects to submit a pre-market approval application (PMA) for Epi proColon^® 2.0 to the FDA before year-end 2011. Contact Epigenomics AG Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 368
pr@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon^®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A. Epigenomics legal disclaimer. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> Epi proColon Company 2011 Fri, 06 May 2011 09:30:00 +0200 Epigenomics AG: Partner Quest Diagnostics Septin9 Test ColoVantage Approved by New York State http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-staat-new-york-erteilt-zulassung-fuer-septin9-test-colovantage-von-partner-quest-dia.html Berlin, Germany, and Seattle, WA, USA
ColoVantage™ is based on Epigenomics’ proprietary DNA methylation technology and^mSEPT9 biomarker licensed non-exclusively to Quest Diagnostics in 2008. New York State is the only State in the U.S. where laboratory-developed tests require explicit approval for patient testing. With this approval, ColoVantage™ is now available in the entire United States.

In a press release issued yesterday by Quest Diagnostics Jon R. Cohen, M.D., senior vice president and chief medical officer, Quest Diagnostics, commented:

“ColoVantage is a convenient, noninvasive option for the millions of patients 50 years of age and older who resist testing by recommended screening methods. As a technique that patients may actually use, ColoVantage is arguably the first practical testing option to promote meaningful cancer evaluation among this large underserved population. It is fitting that March, colorectal cancer awareness month, marks the date our test met New York’s rigorous regulatory criteria.”

Contact Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 0
pr@epigenomics.com
www.epigenomics.com

Notes to the Editor

Quest Diagnostics’ Press Release

Please find yesterday’s press release issued by Quest Diagnostics at
http://questdiagnostics.mediaroom.com/index.php?s=43&item=445

About Epigenomics

Epigenomics (www.epigenomics.com) is a cancer molecular diagnostics company developing and commercializing a pipeline of proprietary products. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics’ legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> Epi proColon Company 2011 Fri, 18 Mar 2011 00:00:00 +0100 Epigenomics and QIAGEN Sign Collaboration Agreement in Colorectal Cancer Blood Testing http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-und-qiagen-unterzeichnen-kooperationsvereinbarung-fuer-darmkrebs-bluttest.html QIAGEN acquires options to mSEPT9 biomarker and DNA methylation technologies; QIAGEN granted... Berlin, Germany and Seattle, WA, U.S.A. Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostics company, and QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced that the companies have entered into an option agreement allowing QIAGEN to develop and, should QIAGEN exercise the option, commercialize a colorectal cancer blood test based on Epigenomics’ proprietary biomarker ^mSEPT9 and certain DNA methylation analysis technologies. Under the terms of the agreement, QIAGEN receives an option to a worldwide non-exclusive commercial license to Epigenomics’ proprietary ^mSEPT9 biomarker and DNA methylation technologies for the detection of colorectal cancer in blood. The option can be exercised by QIAGEN within the next two years. Furthermore, Epigenomics has granted QIAGEN a research license to the mSEPT9 biomarker and the technologies. Under this license, QIAGEN is currently developing a novel sample preparation technology that meets the requirements for the future broad implementation of methylation-based molecular diagnostics, such as Septin9-targeted blood testing for the detection of colorectal cancer, on QIAGEN’s modular molecular testing platform QIAsymphony. Epigenomics will support QIAGEN in the R&D phase through know-how transfer and the collection of clinical specimens as required.
Geert Nygaard, CEO of Epigenomics, commented: “With a clear focus on cancer molecular diagnostics and proven excellence in its fully integrated sample preparation and assay technology platforms for molecular testing, QIAGEN is an ideal further partner to give laboratories and thereby physicians and patients broad access to colorectal cancer blood testing as a convenient addition to currently available methods for early detection. This new agreement significantly expands our existing long-lasting and successful partnership with QIAGEN, and we are looking forward to moving this project to the next stage.” Under the terms of the option agreement, Epigenomics will receive an upfront payment from QIAGEN and will be reimbursed for any R&D support and clinical specimens provided during the R&D phase. Upon QIAGEN exercising the option Epigenomics would receive a further license payment. Once QIAGEN commercializes a colorectal cancer blood test based on Epigenomics’ biomarkers and technology, Epigenomics would be entitled to royalties on QIAGEN’s net sales as well as certain commercial milestones upon reaching specific revenue targets. “This agreement adds to our content pipeline and further broadens the menu of assays optimized for superior performance on our novel modular QIAsymphony and QIAensemble platforms”, says Ulrich Schriek, Vice President Global Business Development at QIAGEN. ”QIAGEN has several ongoing programs which target to expand our “Prevention” assay portfolio which currently includes infectious disease assays as well as HPV screening for the early detection of cervical cancer risks. Prevention assays are key contributors to early detection of disease and to significant reduction of disease burden.” By signing this agreement with QIAGEN, Epigenomics continues to implement its dual business strategy of direct global commercialization of its colorectal cancer blood test, under its own brand name Epi proColon, and non-exclusive licensing of its proprietary ^mSEPT9 biomarker and DNA methylation technologies to leading companies in the diagnostic industry. Epigenomics employs this strategy to maximize access to colorectal cancer blood testing on a range of diagnostic instrument platforms and accelerate adoption of this innovative and patient-friendly approach to the early detection of colorectal cancer. Today, Septin9 blood testing for colorectal cancer is available in Europe, the Middle East, Asia/Pacific and the U.S.A. based on CE-marked diagnostic products and laboratory-developed tests by Epigenomics and its licensing partners.

Contact Epigenomics AG

Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Phone: +49 (0) 30 24345 0
pr@epigenomics.com
www.epigenomics.com Notes to the Editor

About the Septin9 Biomarker and Colorectal Cancer Blood Tests

The ^mSEPT9 biomarker is at the core of the world’s first molecular diagnostic blood tests for the detection of colorectal cancer commercialized by Epigenomics (Epi proColon) and its partner Abbott Molecular (mS9) as IVD test kits in Europe and Asia/Pacific and its licensees Quest Diagnostics (ColoVantage™), ARUP Laboratories (Methylated Septin9 Test), and Warnex Laboratories (Septin9 Test) as laboratory-developed tests in the US and Canada, respectively. The tests all detect cell-free methylated DNA of the SEPT9 gene, which is indicative of the presence of colorectal cancer. In numerous studies, Epigenomics and its partners have demonstrated that the detection of the ^mSEPT9 biomarker in blood plasma correlates with the presence of colorectal cancer and thus can be used as an aid in the detection of this common cancer. These studies include the successfully completed PRESEPT Study, a prospective evaluation of the Septin9 biomarker in a cohort of almost 8,000 individuals representative of a typical screening population. Today, ^mSEPT9 is likely the most thoroughly tested and best studied molecular diagnostic biomarker for colorectal cancer detection. Lack of patient adherence to screening recommendations is the biggest hurdle to an effective screening for colorectal cancer. Experts believe that a blood test that is more convenient for the patients than stool tests and colonoscopy could encourage more people to be screened and thus be of medical and health economic benefit.

About Epigenomics

Epigenomics (www.epigenomics.com) is a cancer molecular diagnostics company developing and commercializing a pipeline of proprietary products. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.. Epigenomics’ legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.

About QIAGEN

QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated bio-molecules visible. QIAGEN has developed and markets more than 500 sample and assay products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer, as well as a broad suite of solutions for infectious disease testing and companion diagnostics. QIAGEN employs nearly 3,600 people in over 35 locations worldwide. Further information about QIAGEN can be found at www.qiagen.com. QIAGEN’s legal disclaimer. Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results, and to expected growth of QIAGEN's business in India in particular, are forward-looking, such statements are based on current expectations that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations and risks of dependency on logistics), variability of operating results, the commercial development of the applied testing markets, clinical research markets and proteomics markets, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's products (including fluctuations due to the level and timing of customers' funding, budgets, and other factors), our ability to obtain regulatory approval of our infectious disease panels, difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products, the ability of QIAGEN to identify and develop new products and to differentiate its products from competitors' products, market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).]]> Company Epi proColon 2011 Mon, 28 Feb 2011 00:00:00 +0100 Epigenomics Provides Update on Progress with US Product Development for Epi <i>pro</i>Colon http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-berichtet-ueber-fortschritte-bei-entwicklung-des-epi-procolon-produkts-fuer-die-usa.html - Strong feasibility study data for improved product concept with 91% sensitivity and 87%... Berlin, Germany, and Seattle, WA, USA Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostic company, today announced that it has concluded the feasibility phase in the development of an improved product concept for Epi proColon, the Company’s DNA methylation-based blood test for assistance in the detection of individuals with colorectal cancer. This improved product concept is being developed for the US market and as a second generation product for the European and other markets. At the same time, the FDA has set a date in February for a Pre-IDE meeting to discuss with Epigenomics the product concept, its intended use and the clinical data required to support an application for marketing of the product in the US. Epi proColon is currently marketed in Europe and a number of other countries outside the USA and its utility in the early detection of colorectal cancer in a blood draw is extensively supported by numerous clinical studies. While the new assay measures the same epigenetic information in the Septin9 gene, design changes have been implemented that are based on the findings in the more recent studies performed by Epigenomics and its partners as well as feedback from current customers in Europe and market surveys in the US. The new device will use reagents manufactured under the cGMP standard and a real-time PCR platform that has previously been cleared by the FDA for use with diagnostic assays. Performing the assay will require fewer components and handling steps and results can be obtained within a typical laboratory work shift of 8 hours. Further, the new assay will have improved automation capabilities. In a feasibility study that included 97 colorectal cancer patients and 159 colonoscopy-confirmed controls in the improved assay had a sensitivity for cancer of 91% at 87% specificity. In this study, the test was able to identify 21 out of 27 Stage I cancer cases (78%) and 25 out of 25 Stage II cancer cases (100%). This is particularly important as patients with Stage I and II of colorectal cancer have a combined five year survival of about 90% and early clinical interventions are effective in improving survival. Dr. Uwe Staub, Senior Vice President Product Development at Epigenomics said: “The excellent results of this feasibility study are a direct reflection of the improvements we have made to the test. Following our upcoming dialogue with the FDA, we hope to be able to finalize our clinical validation plan for the intended use of the improved test and later this year run the pivotal study using the samples already collected as part of the prospectively enrolled PRESEPT cohort. It should be noted that the higher proportion of pT1 subgroup of Stage I cases may mean that the sensitivity in a prospective evaluation would not be as high as we have just seen in the feasibility study.” Geert Nygaard, Chief Executive Officer of Epigenomics added: “We are delighted to have this confirmation that the improvements and adaptations we made to the assay should result in a product that meets USFDA as well as European regulatory and market requirements but also shows potentially improved clinical performance. We are looking forward to our upcoming discussions with the FDA, which commence shortly. Once those discussions conclude in the period following our face-to-face meeting we will be in the position to provide more detail on the next steps towards launching our Epi proColon test in the US.” The Company also intends to make the improved next generation Epi proColon product available in Europe and other markets once it has been adapted to the LightCycler 480 as well as the AB7500 instruments currently used in these markets. The second generation product is likely to reach these markets by during the second half of 2011.

Contact Epigenomics AG

Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Phone: +49 (0) 30 24345 368
pr@epigenomics.com
www.epigenomics.com

About Epigenomics

About Epi proColon

Epi proColon, developed by Epigenomics, is a test for the detection of methylated DNA of the Septin9 gene in blood plasma. Detection of this Septin9 biomarker in blood plasma has been shown in numerous clinical studies to be closely associated with the presence of colorectal cancer and may aid in the detection of this common cancer. Septin9 is one of the best and most systematically validated biomarkers for the early detection of colorectal cancer today. In particular, the recent PRESEPT Study was a successful prospective evaluation of Epi proColon detection of methylated Septin9 in a cohort of about 8,000 individuals representative of a typical screening population. Lack of patient adherence to screening recommendations is the biggest hurdle to an effective screening for colorectal cancer. Experts believe that a blood test that is more convenient for the patients than stool tests and colonoscopy could help to get more people screened and thus be of medical and health economic benefit. Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.]]> Company Epi proColon 2011 Thu, 13 Jan 2011 00:00:00 +0100 Warnex Launches Colorectal Cancer Blood Testing Service in Canada Using Epigenomics’ Septin9 Biomarker http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-partner-warnex-startet-vermarktung-von-septin9-bluttest-fuer-darmkrebs-in-kanada.html Berlin, Germany, and Laval, QC, Canada Epigenomics AG (Frankfurt Prime Standard: ECX), a cancer... Berlin, Germany, and Laval, QC, Canada Epigenomics AG (Frankfurt Prime Standard: ECX), a cancer molecular diagnostics company and Warnex Medical Laboratories, a division of Warnex Inc. (TSX: WNX), today announced the launch of a molecular diagnostic blood testing service for colorectal cancer in Canada, based on Epigenomics’ patented biomarker Septin9 and DNA methylation technologies. Warnex is the first laboratory to offer Septin9 testing in Canada, after obtaining the non-exclusive rights from Epigenomics in May 2010. Prior to its launch, Warnex’s Septin9 test was independently developed and successfully validated using clinical blood samples from colorectal cancer patients and individuals with no apparent disease as verified by colonoscopy. “Colorectal cancer is curable if caught early enough and blood tests like this may play an important role in saving lives. We are delighted that patients in Canada will now also be able to benefit from Septin9 testing, alongside patients in the United States, Europe and the Middle East,” commented Geert Nygaard, Chief Executive Officer of Epigenomics. “We are pleased to add this colorectal cancer test based on real-time PCR technology to our service offering as part of our continued commitment to delivering the most advanced specialized diagnostic services to Canadian healthcare professionals,” said Mark Busgang, President and CEO of Warnex. “The Septin9 test is a convenient and specific blood test for colorectal cancer detection that can easily be integrated into the patient’s routine physical, as it is non-invasive and does not require any drug or dietary restrictions.” Colorectal cancer is the second-leading cause of cancer deaths in Canada. In 2009, an estimated 22,000 Canadians were diagnosed with the disease and 9,100 died from it. As colorectal cancer is largely curable when detected in early, still localized stages, the Colorectal Cancer Association of Canada recommends that all Canadians age 50 and over undergo screening with a test detecting blood in stool (fecal occult blood test or fecal immunochemical test) at least once every two years. If a test is positive for blood, a colonoscopy should be performed to determine the cause of bleeding. Despite the clear benefits of colorectal cancer screening in reducing mortality from this disease, only 4% to 14% of eligible Canadians follow the screening recommendations. Innovative convenient screening methods could greatly increase compliance with current guidelines and thereby contribute to reducing mortality from colorectal cancer.
---
Note to the editor To view the brochure for Warnex’s Septin9 Blood Test, please follow this link

Contact Epigenomics AG

Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Phone: +49 (0) 30 24345 368
pr@epigenomics.com

Contact Warnex

Catherine Sartoros
Communications Specialist
Warnex Inc.
Tel +1 450-663-6724 x 277
csartoros@warnex.ca

About Epigenomics

Epigenomics AG is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests on the market and in development for colorectal, lung, and prostate cancer aim at aiding in an earlier and more accurate diagnosis of these diseases, thereby potentially increasing the patient’s chances of survival. For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Sysmex Corporation, Quest Diagnostics Incorporated, ARUP Laboratories, Inc., and Warnex Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, USA. For more information, please visit Epigenomics’ website at www.epigenomics.com. About Warnex Warnex (www.warnex.ca) is a life sciences company devoted to protecting public health by providing laboratory services to the pharmaceutical and healthcare sectors. Warnex Analytical Services provides pharmaceutical and biotechnology companies with a variety of quality control services, including chemistry, chromatography, microbiology, method development and validation, and stability studies. Warnex Bioanalytical Services specializes in bioequivalence and bioavailability studies for clinical trials. Warnex Medical Laboratories provides specialized testing for the healthcare industry as well as pharmaceutical and central laboratory services. Warnex PRO-DNA Services offers DNA identification tests for paternity, maternity and other family relationships, as well as for immigration and forensic testing purposes. Warnex has three facilities located in Laval and Blainville, Quebec, and Thunder Bay, Ontario. Caution regarding forward-looking statements by Warnex. Certain statements contained in this news release are forward-looking and are subject to numerous risks and uncertainties, known and unknown. For information identifying known risks and uncertainties, relating to financial resources, liquidity risk, key customers and business partners, credit risk, foreign currency risk, government regulations, laboratory facilities, volatility of share price, employees, suppliers, and other important factors that could cause actual results to differ materially from those anticipated in the forward-looking statements, please refer to the heading Risks and Uncertainties in Warnex's most recent Management's Discussion and Analysis, which can be found at www.sedar.com. Consequently, actual results may differ materially from the anticipated results expressed in these forward-looking statements. Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States of America or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the United States of America or Canada have not been established.]]> Company Epi proColon 2010 Mon, 06 Dec 2010 00:00:00 +0100 Epigenomics Initiates Clinical Market Observation Study for Colorectal Cancer Blood Test http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-startet-klinische-marktbeobachtungsstudie-fuer-blutbasierten-darmkrebstest.html Berlin, Germany, and Seattle, WA, U.S.A. Epigenomics AG, the cancer diagnostics company,... Epigenomics AG, the cancer diagnostics company, today announced that they have initiated an observational clinical study for the Epi proColon test to examine adoption patterns in the marketplace. Epi proColon is the world’s first CE-marked molecular diagnostic test for the early detection of colorectal cancer in blood. This diagnostic laboratory test was first launched in October 2009 in Europe and is currently being marketed by Epigenomics to privately insured individuals and self-payors in Germany, Austria and Switzerland and through distributors in other markets. With the clinical performance of the test’s underlying biomarker, Septin9, well established in numerous case control studies and a large prospective screening study, the current study focuses on behavioral and demographic aspects of current users of the test. The observational study is expected to include approximately 300 primary care physicians, enrolling up to 3,000 patients taking the Epi proColon test in Germany and Switzerland. The study, which has recently already been cleared by the Berlin Ethics Board, is expected to be fully enrolled in 2011. “While the preparedness to pay out of pocket among patients in Switzerland is very high, Germans still tend to rely mostly on the public health care system”, explained Dr. Juergen Beck, Senior Vice President Medical Affairs at Epigenomics. “The only non-invasive alternative to colonoscopy for colorectal cancer screening that is currently reimbursed under the German public scheme is a chemical stool test, which is outdated in performance and lacks convenience and patient-friendliness. With this new study, we expect to learn more about those individuals that opt to use our convenient blood test. We expect the results of this study to help with both fine-tuning the positioning of the test in the self-payor market segment and in seeking general reimbursement under the public health care scheme.”

Contact Epigenomics AG

Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 0
pr@epigenomics.com
www.epigenomics.com

About Epigenomics

Epi proColon

Epi proColon, developed by Epigenomics, is a CE-marked test kit for the detection of methylated DNA of the Septin9 gene in blood plasma. This Septin9 biomarker has been shown in numerous clinical studies to be closely associated with the presence of colorectal cancer and may aid in the detection of this common cancer. Septin9 is one of the best and most systematically validated biomarkers for the early detection of colorectal cancer today. In particular, the recent PRESEPT Study was a successful prospective evaluation of Epi proColon detection of methylated Septin9 in a cohort of about 8,000 individuals representative of a typical screening population. Epigenomics’ legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States of America. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the USA have not been established.]]> Company Epi proColon 2010 Tue, 23 Nov 2010 00:00:00 +0100 Epigenomics Signs Distribution Deal with DPC for Epi proColon in Middle East http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-unterzeichnet-vertriebsvereinbarung-mit-dpc-fuer-epi-procolon-in-nahost.html Third distribution agreement for Epi proColon completes the picture for the Middle East Berlin, Germany, and Seattle, WA, U.S.A. Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer diagnostics company, today announced that the company has signed an exclusive distributor agreement with DPC LEBANON for the commercialization of Epigenomics’ Epi proColon test in Lebanon, United Arab Emirates, Saudi Arabia, Qatar, Kuwait, Syria, Jordan and Egypt. Epi proColon is the world’s first CE-marked molecular diagnostic test for the early detection of colorectal cancer in blood. The test uses Epigenomics’ proprietary colorectal cancer biomarker Septin9 in blood plasma. DPC expects to begin marketing the test in the next few weeks. Colorectal cancer is the third leading cause of cancer-related death in the Western world and is also major threat to public health throughout the Middle East. The disease is highly curable when detected at an early still localized stage. Survival chances, however, diminish once the tumor has spread to distant organs and the disease has become obvious with patients showing symptoms. “We are delighted to be commercializing Epi proColon in Lebanon and throughout the Middle East,” Leila Macaron, General Manager of DPC commented. “Early detection of colorectal cancer is critical to the effective treatment of this disease and we believe that this blood test is a simple procedure that can be easily incorporated into clinical regimes and screening programs.” “Signing this deal with DPC completes the picture for the Middle East following our recent deals in Turkey and Israel,” commented Geert Nygaard, Chief Executive Officer of Epigenomics. “DPC will join DATEKS and Pronto as important partners in our continuously growing distributor network for our Epi proColon product” Epi proColon is currently marketed by Epigenomics directly in Germany, Austria and Switzerland. Outside this home market, it is Epigenomics’ strategy to make the CE-marked test broadly available through a mix of direct commercialization and a distributor network. ---
Notes for editors

Contact Epigenomics AG

Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 368
pr@epigenomics.com
www.epigenomics.com

About Epigenomics

Epi proColon

Epi proColon, developed by Epigenomics, is a CE-marked test kit for the detection of methylated DNA of the Septin9 gene in blood plasma. This Septin9 biomarker has been shown in numerous clinical studies to be closely associated with the presence of colorectal cancer and may aid in the detection of this common cancer. Septin9 is one of the best and most systematically validated biomarkers for the early detection of colorectal cancer today. In particular, the recent PRESEPT Study was a successful prospective evaluation of Epi proColon detection of methylated Septin9 in a cohort of about 8,000 individuals representative of a typical screening population. Epigenomics’ legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States of America. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the USA have not been established.]]> Company Epi proColon 2010 Fri, 05 Nov 2010 00:00:00 +0100 Epigenomics AG: New Clinical Data for Septin9 Colorectal Cancer Blood Test Presented at UEGW http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-praesentiert-neue-klinische-daten-zu-septin9-bluttests-fuer-darmkrebs-auf-der-uegw.html Independent validation of laboratory test used in PRESEPT Study shows that the test finds 86% of... Berlin, Germany, and Seattle, WA, U.S.A. Epigenomics AG, the cancer diagnostics company, announced that new data obtained in a clinical study with the Company’s proprietary Septin9 biomarker for the blood-based detection of colorectal cancer were presented yesterday at the 18th United European Gastroenterology Week (UEGW) in Barcelona, Spain. The new data were presented by Dr. Juergen Beck, MD, who recently joined Epigenomics as Senior Vice President Medical Affairs, and validate findings in the successfully completed prospective PRESEPT Study, also presented at the conference. In the PRESEPT Study, Epigenomics’ proprietary Septin9 blood test detected 67% of the colorectal cancer cases at a specificity of 88% when compared to colonoscopy, the gold standard in colorectal cancer detection. PRESEPT is a prospective evaluation of the Septin9 biomarker in a study cohort representative of the screening population for colorectal cancer. Almost 8,000 individuals undergoing colonoscopy for routine colorectal cancer screening were enrolled at 32 clinical sites in the US and Germany over a period of about 18 months in this benchmark study. The study was sponsored by Epigenomics, the discoverer of the Septin9 biomarker. It is the largest privately sponsored study in colorectal cancer screening ever conducted. In his poster presentation, Dr. Beck further presented data obtained in a smaller case-control study following the large PRESEPT Screening Study to independently validate the diagnostics assay that had been used in the PRESEPT Study. Investigators in an independent third-party laboratory analyzed cancer cases and colonoscopy-negative controls following the PRESEPT testing protocol. Within this study, the data of which have not been presented before, a sensitivity of 86% and a specificity of 93% were observed. ”The prospective PRESEPT Study has established that a plasma-based marker can be used to detect colorectal cancer in asymptomatic individuals”, concluded Prof. Dr. Thomas Roesch, Medical Director of the Department of Interdisciplinary Endoscopy at the University Hospital Hamburg-Eppendorf and Study Director of PRESEPT in Germany. “Further investigations will look into acceptance and uptake to determine whether the Septin9 test will help to get more people screened for colorectal cancer as well as cost-benefit aspects.” Prof. Roesch was chairing a round table of international colorectal cancer screening experts to review and discuss the results of the PRESEPT Study. The round table was jointly organized by Epigenomics and its commercialization partner Abbott Molecular and took place in Barcelona concurrent with the UEWG. Both companies offer CE-marked diagnostic (IVD) test for the detection of the Epigenomics’ proprietary Septin9 biomarker in blood plasma as an aid in the detection of colorectal cancer in Europe and Asia/Pacific. Epigenomics and Abbott Molecular are also working on making Septin9 assays available as FDA-cleared IVD test kits for the US market. “The PRESEPT Study and the independent validation of the assay system used demonstrates the clinical utility of Septin9 testing as an aid in the detection of colorectal cancer when followed up with colonoscopy and underscores once again the unique potential of our proprietary Septin9 biomarker,” commented Geert Nygaard, Chief Executive Officer of Epigenomics. “As a single biomarker test, the Septin9 test compares very favorably in terms of clinical performance and simplicity of handling and interpretation to emerging competing molecular diagnostic approaches to stool and blood testing for colorectal cancer.” - Ends-

Contact Epigenomics AG

Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 368
pr@epigenomics.com
www.epigenomics.com Notes to Editors

About Epigenomics

About the Septin9 Biomarker and Colorectal Cancer Blood Tests

The Septin9 biomarker is at the core of the world’s first molecular diagnostic blood tests for the detection of colorectal cancer commercialized by Epigenomics (Epi Colon) and its Partner Abbott Molecular (S9) as IVD test kits in Europe and Asia/Pacific and its licensees Quest Diagnostics (ColoVantage™) and ARUP Laboratories (Methylated Septin9 Test) as laboratory-developed tests in the US. The tests all detect cell-free methylated DNA of the Septin9 gene shed into the blood stream by colorectal tumors. In numerous studies, Epigenomics and its partners have demonstrated that the detection of the Septin9 biomarker in blood plasma correlates with the presence of colorectal cancer and thus can be used as an aid in the detection of this common cancer. These studies include the successfully completed PRESEPT Study, a prospective evaluation of the Septin9 biomarker in a cohort of almost 8,000 individuals representative of a typical screening population. Today, Septin9 is likely the most thoroughly tested and best studied molecular diagnostic biomarker for colorectal cancer detection. Lack of patient adherence to screening recommendations is the biggest hurdle to an effective screening for colorectal cancer. Experts believe that a blood test that is more convenient for the patients than stool tests and colonoscopy could help to get more people screened and thus be of medical and health economic benefit. Epigenomics’ legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States of America. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the USA have not been established. ]]> Company Epi proColon 2010 Wed, 27 Oct 2010 00:00:00 +0200 Epigenomics AG: Partnership with Laboratory Network MDI – A Successful Model for Introducing Blood-based Colorectal Cancer Early Detection http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-partnerschaft-mit-labornetzwerk-mdi-ein-erfolgsmodell-bei-der-einfuehrung-der-blutb.html Innovative Septin9 blood-test offers new opportunities in colorectal cancer early detection...
“For MDI laboratory colorectal cancer early detection has very high priority”, commented Dr. Heinz-Detlef Gremmels, Head of the MDI laboratory in Berlin. “By offering the Septin9 test we provide to our clients an innovative and simple alternative to current methods of colorectal cancer early detection. The education in this field we provide to physicians together with Epigenomics has triggered many requests for the Septin9 test and a steadily increasing number of patient samples arriving at the labs for analysis with this colorectal cancer blood test.” Dr. Gremmels added that MDI expects to successfully establish the new Septin9 parameter within 12 months in northern and eastern Germany.

The Septin9 colorectal cancer blood test is designed to be convenient and patient friendly: patients simply provide a blood sample in the doctor’s office, e.g. as part of a regular health check-up. The blood sample is then shipped to a diagnostic laboratory where it is tested for presence of the Septin9 biomarker.

Current colorectal cancer screening methods – including fecal occult blood tests (FOBT) and colonoscopy – are perceived to be inconvenient and laborious and are infrequently used by individuals aged 50 and older who should be screened at regular intervals. Therefore the majority of cancers are detected in advanced stages when the chances of survival are greatly diminished. The blood-based Septin9 test provides an opportunity to motivate more people to participate in early detection schemes and to provide an earlier and more promising therapy to those individuals with cancer among them.

With the aim of educating physicians and patients in the Berlin and Brandenburg area about this novel approach in colorectal cancer early detection this year, in addition to sending large numbers of information letters to regional physicians, MDI laboratory has been organizing numerous educational seminars in five German states, which have generated positive interest among the participating medical professionals. In close collaboration with Epigenomics and with key opinion leaders in gastroenterology as speakers, the MDI laboratory informs attendees on colorectal cancer as well as benefits and methods of colorectal cancer early detection, including the innovative blood-based Septin9 test. These seminars offer a novel platform for information exchange between laboratories, gastroenterologists and family doctors on the topic of colorectal cancer. Epigenomics further supports this educational process by working closely with lay and trade press, and providing scientific contributions at medical conferences and patient-oriented educational events.

Dr. Frieda Gerdes, Head of Marketing at Epigenomics emphasizes the advantages of such a partnership: “Close collaboration with the laboratories offers many advantages: It provides us the opportunity to introduce the Septin9 test to a vast group of family doctors very efficiently and enter into a close dialog with them. We plan to implement this concept also with other laboratory networks to introduce the Septin9 test to more doctors and patients as an alternative to current non-invasive methods in order to encourage more people to participate in colorectal cancer early detection.”

MDI laboratory and Epigenomics also intend to perform scientific studies with the aim to support the introduction of the Septin9 test into medical practice and to provide important insight into behavioral aspects of acceptance of colorectal cancer early detection in the target screening population.

A recently performed market survey among primary care physicians in Germany performed by DocCheck, an online portal for medical professionals, on behalf of Epigenomics shows that close cooperation with the laboratories is already bearing fruit: Since the introduction in October 2009 already 34% of all physicians surveyed have heard about the Septin9 test with the majority of them having a positive attitude towards the test.

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests on the market and in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product portfolio contains the CE-marked IVD test, Epi proColon, the world’s first regulatory cleared molecular diagnostic test for the detection of colorectal cancer in blood that is based on the biomarker Septin9, and further proprietary DNA methylation biomarkers and IVD products at various stages of development for colorectal, lung and prostate cancer. For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product outside of the European Union, and no product based on this technology is currently available for sale in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established.
]]> Epi proColon Company 2010 Thu, 17 Jun 2010 00:00:00 +0200 PRESEPT Study Results Sponsored by Epigenomics AG Presented at Digestive Disease Week http://www.epiprocolon.com/forum/nachrichten/article/ergebnisse-der-von-epigenomics-gesponserten-presept-studie-auf-digestive-disease-week-vorgestellt.html mSEPT9 biomarker successfully validated as the first biomarker in blood capable of detecting...
The results were presented by Timothy R. Church, Ph.D., University of Minnesota, Minneapolis, MN, U.S.A., Principal Investigator of the PRESEPT Study on behalf of the PRESEPT Clinical Study Steering Committee. The presentation summarized the results obtained from testing three replicates for the presence of ^mSEPT9, which exhibited a sensitivity of 66.7 % at a specificity of 88.4% in this cohort.

The final data of the PRESEPT Study will be submitted for publication to a top-tier journal for peer review in due course.

Dr. Catherine Lofton-Day, Vice President Molecular Biology and project manager of the PRESEPT Study at Epigenomics explained: “We are very pleased with the results of our PRESEPT Study. The results show that our ^mSEPT9 test meets the requirements for routine use in a true screening population and could provide an attractive alternative for patients not willing to accept current screening methods. Furthermore the test could have the potential to resolve the problem of poor patient compliance in CRC screening.”

The PRESEPT Study is one of the largest commercially sponsored colorectal cancer screening clinical studies ever conducted. Between June 2008 and December 2009, in total 7,940 screening eligible average risk subjects were enrolled into the PRESEPT Study at 32 clinical sites in the U.S. and Germany. This study population contained 53 cases of previously unsuspected colorectal cancers that were identified by screening colonoscopies performed on all study participants. Over two-thirds of the 53 colorectal cancer cases identified in the cohort were early stage disease (Stages I and II) with a large proportion of the stage I colorectal cancer cases being very early stage disease (histopathologically described as pT1).

Tim Church on behalf of the CSSC concluded that this prospective, blinded study validates that a plasma-based marker can be used to detect preclinical colorectal cancer in asymptomatic individuals.

A simple blood test for colorectal cancer screening that is available for the large group of eligible patients, who are unwilling or unable to use other available methods, has the potential to address the lack of compliance with today’s screening approaches. Based on the ^mSEPT9 marker performance data and the prevalence of colorectal cancer observed in the PRESEPT Study cohort, a primary care physician informing a patient of a ^mSEPT9 test result that is negative for colorectal cancer can do so with the confidence of it being correct 99.7% of the time (Negative Predictive Value).

Geert Nygaard, CEO of Epigenomics AG, further stated: “Having demonstrated the performance of our ^mSEPT9 biomarker in this prospective screening cohort is of tremendous value to our efforts of securing guideline inclusion and reimbursement in the major markets and thereby making a convenient blood-based colorectal cancer screening test available to the broader population.”

2010 Digestive Week Presentation Details and other Activities

The presentation titled “Prospective clinical validation of an assay for methylated SEPT9 DNA in human plasma as a colorectal cancer screening tool in average risk men and women 50 years and older” presented by Timothy R. Church, PhD. has been held at the Digestive Disease Week 2010 (from May 1 – May 5, 2010), in New Orleans during a Late-Breaking Abstracts Session on Tuesday, May 4, 2010.

Furthermore Dr. Catherine Lofton-Day Vice President Molecular Biology and project manager of the PRESEPT Study at Epigenomics held a presentation titled “Looking into alternatives: blood-based tests for CRC screening” at the World Organization of Digestive Endoscopy (OMED) Meeting.

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests on the market and in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product portfolio contains the CE-marked IVD test Epi proColon, the world’s first regulatory cleared molecular diagnostic test for the detection of colorectal cancer in blood that is based on the biomarker mSEPT9, and further proprietary DNA methylation biomarkers and IVD products at various stages of development for colorectal, lung and prostate cancer. For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com. Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product outside of the European Union, and no product based on this technology is currently available for sale in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established.

]]> Epi proColon Company 2010 Fri, 07 May 2010 00:00:00 +0200 Epigenomics AG: Laboratory Network synlab Now Offering Septin9 Testing http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-laborverbund-synlab-bietet-septin9-test-an.html European diagnostic laboratory network synlab has started offering Septin9 blood testing through... proColon for colorectal cancer early detection through its 55 German sites. The test which is able to detect colorectal cancer in a simple blood draw is based on Epigenomics’ patented Septin9 biomarker and is the first regulated molecular diagnostic blood test ever for colorectal cancer early detection offered in Europe. The test was introduced in October 2009 as a CE-marked in vitro diagnostic product in Europe. Additional offering of Septin9 testing through the synlab network significantly increases coverage in Germany as well as other countries making this innovative test even more broadly available to doctors and patients in Europe.

Current colorectal cancer screening methods – including fecal occult blood tests (FOBT) and colonoscopy- are perceived to be inconvenient and laborious and are reluctantly and infrequently used by individuals aged 50 and older who should be screened at regular intervals. This lack of compliance to screening recommendations severely limits the effectiveness of national screening programs as the majority of cancer cases are detected in advanced stages when symptoms occur and the chances of survival are greatly diminished.

The Septin9 colorectal cancer blood test is designed to be as convenient and patient friendly as possible: patients simply provide a blood sample in their doctors’ office, e.g. as part of a regular health check-up. The sample is then shipped to a local, regional or national diagnostic laboratory where it is tested for the Septin9 biomarker.

Dr. Wolfgang Schwabe, Head of Oncoscreen GmbH, Jena, the laboratory running the Septin9 test within the synlab network, stated: “We are excited by the potential of the Septin9 test to help doctors provide more convenient patient care. With the Septin9 test we have broadened our portfolio of oncology services which allows us to offer a more complete package of diagnostic services to doctors and their patients.”

The test is based on the detection of methylated Septin9 DNA in blood. This epigenetic modification of the Septin9 gene can be detected in the vast majority of tumors in the colon and rectum. As tumors shed DNA into the bloodstream, the detection of circulating methylated Septin9 DNA with the sensitive Epi proColon real-time PCR assay is a reliable indicator of acute colorectal cancer.

Oncoscreen is the first laboratory to use a recently released version of the Epi proColon real-time PCR assay to detect the Septin9 biomarker in blood plasma. This reagent kit has now been validated for use with the Applied Biosystems 7500 Fast Real-Time PCR System of Life Technologies Inc. as well as Roche’s LightCycler^®480 instrument on which the test was originally released in October 2009. Availability on two standard real-time PCR instrument platforms found in many clinical laboratories is expected to further facilitate making Septin9 testing broadly available in Europe.

“The Septin9 assay is very robust and can easily be optimized for different real-time PCR instruments, the standard technology platform in molecular diagnostics”, commented Dr. Uwe Staub, Senior Vice President Product Development at Epigenomics. “This allows us as well as our partners to make Septin9 testing available as broadly as possible, an important prerequisite for a test that should eventually be used in population wide colorectal cancer screening.”

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests on the market and in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product portfolio contains the CE-marked IVD test Epi proColon, the world’s first regulatory cleared molecular diagnostic test for the detection of colorectal cancer in blood that is based on the biomarker Septin9, and further proprietary DNA methylation biomarkers and IVD products at various stages of development for colorectal, lung and prostate cancer. For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established.
]]> Epi proColon Company 2010 Wed, 07 Apr 2010 00:00:00 +0200 Epigenomics AG: Blood Test for Colorectal Cancer Now Available Nationwide in Germany and Switzerland http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-darmkrebs-bluttest-jetzt-flaechendeckend-in-deutschland-und-der-schweiz-verfuegbar.html Colorectal cancer test Epi proColon now available nationwide in Germany and Switzerland four months... ^mSEPT9 and is the first blood test ever for colorectal cancer early detection offered in Europe. The test was introduced in October 2009 as a CE-marked in vitro diagnostic product in Europe. As of today, the test is offered by 16 laboratories in Germany and Switzerland making it available to doctors and patients across both countries.

Current colorectal cancer screening methods – including fecal occult blood tests (FOBT) and colonoscopy – are perceived to be inconvenient and laborious and are reluctantly and infrequently used by individuals aged 50 and older who should be screened at regular intervals. This lack of compliance to screening recommendations severely limits the effectiveness of national screening programs as the majority of cancers are detected in advanced stages when symptoms occur and the chances of survival are greatly diminished.
As one of the laboratory networks operating nationwide, Berlin-based MDI – Medizinisches Diagnostisches Institut –started offering the Septin9 test across Germany in February 2010. “The Septin9 test for the early detection of colorectal cancer provides an attractive alternative to current stool-based tests to our clients”, commented Dr. Heinz-Detlef Gremmels, Head of the MDI laboratory. “We are confident that many patients will prefer this new approach in cancer screening. With the introduction of the sensitive Septin9 test colorectal cancer cases can be detected earlier and the current high mortality rate from colorectal cancer could be reduced significantly.”

The test is based on the detection of methylated Septin9 DNA (^mSEPT9) in blood. This epigenetic modification of the Septin9 gene can be detected in the vast majority of tumors in the colon and rectum. As tumors shed DNA into the bloodstream, the detection of circulating methylated Septin9 DNA with the sensitive Epi proColon assay is a reliable indicator of acute colorectal cancer.
The Septin9 colorectal cancer blood test is designed to be as convenient and patient friendly as possible: patients simply provide a blood sample in the doctor’s office, e.g. as part of a regular health check-up. The sample is shipped to a local, regional or national diagnostic laboratory where it is tested for the ^mSEPT9 biomarker. Recent clinical data from a case control study evaluating the performance of the CE-marked Epi proColon in colorectal cancer detection will be presented in a poster presentation by Epigenomics at the German Cancer Congress tomorrow. During the Congress Epigenomics will also host a press conference on Friday, February 26, 2010 on new epigenetic tests in different cancers including a presentation by Prof. Dr. Thomas Rösch, University Hospital Hamburg-Eppendorf titled “The Medical Need of the Septin9 Test Epi proColon for Colorectal Cancer Early Detection”.

The German Cancer Congress is organized by the German Cancer Society (Deutsche Krebsgesellschaft e.V.) and is the most important oncology forum in German speaking countries.

Epigenomics at the 29th German Cancer Congress

Epigenomics will be represented at the 29^th German Cancer Conference Congress 2010 (Deutscher Krebskongress – DKK) in Berlin, Germany, from February 24^thto 27^th2010, with a booth at the ICC Berlin, Hall 17, booth number B15.
A poster presentation (poster number: PO039) titled “The tumor marker ^mSEPT9 for colorectal cancer early detection: Introduction of current clinical data” will be presented within the Biomarker Session by Dr. Philipp Schatz, Epigenomics AG, Berlin, Germany, on February 24^th, 2010, from 1.15 pm to 2.45 pm, in Hall Koch at the ICC Berlin.

A press conference titled “Innovative biomarkers for the diagnosis of lung- and colorectal cancer: Epigenetic tests open new ways in cancer diagnostics” will take place on Friday, February 26th, 2010, from 1:15 pm to 2:45 pm at the press center on the bridge, Room 43, Messedamm 22 at the ICC Berlin. Presentations will be held by Prof. Dr. Thomas Rösch, University Hospital Hamburg-Eppendorf, Dr. Thomas Mairinger, Helios Hospital Emil von Behring, Berlin-Zehlendorf and Dr. Achim Plum, Epigenomics AG, Berlin.

Interested Journalists and Media are kindly requested to contact Sandra Leinhoss via Email: sandra.leinhoss@epigenomics.com for participation details.

About Epi proColon

Epi proColon is Epigenomics’ CE-marked, in vitro diagnostic real-time PCR test kit for the qualitative detection of Septin9 gene methylation in cell-free bisulfite converted DNA isolated from human plasma samples. Presence of methylated Septin9 DNA is associated with, and may aid in, the detection of invasive colorectal adenocarcinoma.

For more information on the Epi proColon test and its availability and distribution options in Europe please visit www.epiprocolon.com or contact Epigenomics directly by Email sales@products.epigenomics.com or phone +49 30 24345 111.

Epi proColon is not for sale in the United States of America. The analytical and clinical performance characteristics of the product have not been evaluated by the US Food and Drug Administration. The product is CE-marked in compliance with the European IVD Directive 98/79/EC.

About Colorectal Cancer

Colorectal cancer (or colorectal carcinoma) refers to a malignant growth of the colorectal mucosa. Colorectal cancer develops usually in several phases and over many years, beginning with abnormal cell proliferation inside the colon that over the time forms adenomas that, depending on their shape are often referred to as polyps or flat lesions. These benign precursors can become tumors which are initially localized (stage I or II), but over the course of the disease spread into lymph nodes (stage III) and finally metastasize to distant organs such as the liver, bones or lung (stage IV). The development from a small polyp or a flat lesion to a cancer takes an average of 5 to 10 years.

With approximately 72,000 newly diagnosed individuals each year in Germany, colorectal cancer is the second most frequent gastrointestinal tumor among women and men and about 29,000 individuals die from the disease every year. With approximately 4,100 new cases every year Switzerland is the country with the highest colorectal cancer incidence in Europe. In total 10.4% of all cancer-related deaths in Switzerland are caused by colorectal cancer. The five-year survival rate for patients is about 90% if the cancer is diagnosed at an early stage while it is still localized but drops to below 10% in stage IV. As a consequence, the early diagnosis of colorectal cancer is of the highest importance to a successful therapy.

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests on the market and in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product portfolio contains the CE-marked IVD test Epi proColon, the world’s first regulatory cleared molecular diagnostic test for the detection of colorectal cancer in blood that is based on the biomarker Septin9, and further proprietary DNA methylation biomarkers and IVD products at various stages of development for colorectal, lung and prostate cancer. For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established. ]]> Epi proColon Company 2010 Tue, 23 Feb 2010 00:00:00 +0100 Epigenomics AG Reports Conclusions from PRESEPT Study Audit http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-schlussfolgerungen-aus-dem-audit-der-presept-studie.html Differences in analytical instrument read-out requires verification and potential retesting of...
The investigation had been initiated by the Clinical Study Steering Committee (CSSC) following the reporting of preliminary results of the PRESEPT Study on January 15, 2010. These preliminary findings indicated that in two of the three testing laboratories that performed Septin9 testing on blood plasma samples from the PRESEPT Study, subjects achieved cancer detection rates of 62.5% each and therefore were well within expectations. The third laboratory reported a cancer detection rate of 28% which deviated from the findings in the other testing laboratories and all previous eight case control studies on the biomarker that in total included more than 3,300 plasma samples from cancer patients and control subjects. (Refs 1-3)

The thorough audits of the testing laboratories revealed that the analytical instrument used in the laboratory with the divergent results was a recently released new version of the device that was unique to this study laboratory. In the other two laboratories, a different instrument version was used. The audit team observed that the instrument which generated the lower than expected cancer detection rate reported unusually high fluorescence signals in several runs which could have impacted the read-out of results. Those signals could originate from the sample containers used on that device and/or the device itself. This observation was not made in any of the two other laboratories nor any previous study by Epigenomics. The audits at all three testing laboratories, Epigenomics’ internal processes as well as the biostatistics group at the University of Minnesota performed as part of the investigation did not identify significant deviations related to sample traceability, sample handling, or sample processing which could explain the observed results.

Epigenomics will verify the cause for the observed high fluorescent signals and generate data to demonstrate whether and how far this could be responsible for the results observed in the lower cancer detection rate. If necessary, the company will retest study subject samples that were potentially affected by this incident.
In addition to the further investigation into the lower cancer detection rate in the one laboratory and following the recommendations of the CSSC, a small number of additional cancer cases will be tested. These cancer cases were confirmed by pathology after shipping the last testing batches to the laboratories in December. The CSSC had stipulated the testing of these samples in the original study plan to include the results in the final data set to be submitted to a peer-reviewed scientific journal for publication.
The company still expects that all further testing and retesting of samples can be completed within Q1 2010. The company plans to release the updated top-line results from the study including the additional and repeated testing results once they become available.

“We are fully on track in executing on the commercialization of our already launched colorectal cancer blood test, the Epi proColon product”, commented Geert Nygaard, Chief Executive Officer of Epigenomics. “It is important to realize that the PRESEPT Study is an academic medicine study. Its results remain entirely independent of the regulatory pathway such as future FDA approvals and clearances of our Epi proColon product, Abbott’s mS9 assay, or Quest’s ColoVantage test in any current or future market.”
Further information

Conference Calls

Epigenomics’ management has scheduled a conference call for today, February 04, 2010 at 14:00 CET (German language) and 17:00 CET/11:00 am EST (English language) to update on findings in the investigation of outlier results in the PRESEPT Study and planned corrective actions as well as answering questions from investors and media. The dial-in numbers for the conference call are:

Dial-in number (within Germany): +49 (0)69 247 501 899

Dial-in number (within US): +1 212 444 0297

Participants are kindly requested to dial in 10 minutes prior to the start of the call.

A recording of the conference call will be provided on Epigenomics’ website subsequently: http://www.epigenomics.com/en/down_loads/corporate_material/

References

Lofton-Day C, et al. DNA methylation biomarkers for blood-based colorectal cancer screening. Clin Chem. 2008;54(2):414-23.
Grützmann R, et al. Sensitive detection of colorectal cancer in peripheral blood by ^mSEPT9 DNA methylation assay. PLoS One. 2008;3(11):e3759.
deVos T, et al. Circulating methylated SEPT9 DNA in plasma is a biomarker for colorectal cancer. Clin Chem. 2009;55(7):1337-46.

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests on the market and in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product portfolio contains the CE-marked IVD test Epi proColon^®, the world’s first regulatory cleared molecular diagnostic test for the detection of colorectal cancer in blood that is based on the biomarker Septin9, and further proprietary DNA methylation biomarkers and IVD products at various stages of development for colorectal, lung and prostate cancer. For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Philips, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established.

]]> Epi proColon Company 2010 Thu, 04 Feb 2010 00:00:00 +0100 Epigenomics AG: PRESEPT Study Subject Enrollment Successfully Completed http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-aufnahme-von-probanden-in-presept-studie-erfolgreich-abgeschlossen.html 7,852 subjects prospectively enrolled including more than 50 cancer cases Blood samples selected...
PRESEPT is a prospective multi-center clinical research study started in 2008 to evaluate the performance characteristics and health economic benefit of colorectal cancer screening using Epigenomics’ Septin9 blood test in an asymptomatic screening population. Once completed, the PRESEPT Study will likely be the largest privately sponsored colorectal cancer screening studies ever conducted. The PRESEPT screening study follows the successful clinical validation of the Septin9 biomarker as an aid in the diagnosis of colorectal cancer in eight case control studies with in total more than 3,300 colorectal cancer patients and controls conducted by Epigenomics between 2005 and 2009.

With PRESEPT, Septin9 blood testing will be benchmarked against colonoscopy, the gold standard in colorectal cancer diagnosis, to determine the sensitivity and specificity of the Septin9 test for colorectal cancer and different classes of precancerous polyps (adenomas) when applied in its intended use population. Following a predefined statistical analysis plan a subset of about 1,500 of the PRESEPT blood plasma samples were independently selected and are being tested for Septin9. This subset includes blood samples from all confirmed invasive colorectal carcinoma cases, 55 cases with carcinomas in situ, a subset of cases with other advanced adenomas, approximately two hundred randomly selected cases with polyps less than 10 mm and a random selection of about one thousand colonoscopy-verified subjects with no apparent colon disease. The plasma samples to be tested were selected by an independent biostatistics team at the University of Minnesota and subject code and clinical status are masked to the testing laboratories. Following the Septin9 testing of the plasma samples, the test results are sent by the testing laboratories directly to the biostatistics team at the University of Minnesota, where the sample identities will be unmasked and the Septin9 testing data compared to the colonoscopy results and the histopathological findings.

The PRESEPT blood samples are tested in three independent high-profile laboratories, namely Quest Diagnostics Incorporated headquartered in Madison, NJ, U.S.A., ARUP Laboratories, Salt Lake City, UT, U.S.A. and the Institute of Laboratory Medicine and Pathobiochemistry of Charité – Universitätsmedizin Berlin, Germany. The laboratories use Epigenomics’ recently launched CE-marked Epi proColon test kit to detect the Septin9 biomarker. Testing has been ongoing since October 2009 and is in the final stages of completion. After unmasking of the sample identities and data analysis, the Study Principal Investigator, Dr. Timothy Church, University of Minnesota, along with the independent PRESEPT Clinical Study Steering Committee, chaired by Prof. David Ransohoff, University of North Carolina, will report the results of the PRESEPT Study according to all applicable standards of scientific and clinical research.

Epigenomics expects to provide initial results in early 2010 demonstrating whether Septin9 testing using the Epi proColon assay meets the requirements put forth in current US colorectal cancer screening guidelines in detecting “the majority of prevalent or incident cancers at the time of testing”. The detailed data analysis will subsequently be submitted to a top-tier journal for peer review and will be presented at major medical conferences beginning in the first half of 2010.

“With the last subject enrolled we took an amazing step forward on our way to finishing the PRESEPT Study,” stated Cathy Lofton-Day, PhD, Project Manager of PRESEPT at Epigenomics, Inc., Seattle. “A focused effort by our study management staff and devotion to the PRESEPT Study by our many clinical sites allowed us to reach our targeted enrollment numbers and maintain our timeline”, she added.

“We would not have been able to get this far in completing a prospective study of this magnitude and medical importance without the support of our Medical Advisory Board and the PRESEPT Clinical Study Steering Committee”, Michael Wandell, PharmD, PRESEPT Study Director, Epigenomics Inc., Seattle remarked. “We benefited enormously from their guidance and confidence in our design and execution of the study.”

More Information on the PRESEPT Study

For more information on the PRESEPT Study, please visit www.presept.net and www.clinicaltrials.gov (Identifier: NCT00855348).

About the Septin9 test

The Septin9 test was specifically developed for the convenient detection of invasive colorectal carcinomas of all stages and all locations using a blood sample obtained by a routine blood draw. The test concept is based on detecting aberrant DNA methylation of a specific region of the Septin9 gene. Specific Cytosine residues of the DNA in this region become methylated in colorectal cancer tissue but not in normal colon mucosa. This aberrant methylation can be detected by specific amplification of DNA shed into the blood stream by tumor cells. Detection of colorectal cancer DNA in blood samples by testing for methylated Septin9 DNA has been demonstrated in multiple case control studies with more than 3,300 colorectal cancer patients and controls to be a strong indicator (biomarker) for the presence of colorectal cancer. To make Septin9 testing broadly available to doctors and patients, Epigenomics pursues a dual strategy of direct commercialization of the Septin9 test and non-exclusive licensing of the Septin9 biomarker to IVD industry players with broad market access. Licensees include Abbott Molecular, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, Inc.

About Epi proColon^®

Epi proColon^® is Epigenomics’ CE-marked, in vitro diagnostic real-time PCR test kit for the qualitative detection of Septin9 gene methylation in cell-free bisulfite converted DNA isolated from human plasma samples. Presence of methylated Septin9 DNA is associated with, and may aid in, the detection of invasive colorectal adenocarcinoma.

For more information on the Epi proColon test and its availability in Europe please visit www.epiprocolon.com or contact Epigenomics directly by Email sales@products.epigenomics.com or phone +49 30 24345 111.

Epi proColon is not for sale in the United States of America. The analytical and clinical performance characteristics of the product have not been evaluated by the US Food and Drug Administration. The product is CE-marked in compliance with the European IVD Directive 98/79/EC.

About Colorectal Cancer

Colorectal cancer (or colorectal carcinoma) refers to a malignant growth of the colorectal mucosa. Colorectal cancer develops usually in several phases and over many years, beginning with abnormal cell proliferation inside the colon that over the time forms adenomas that, depending on their shape are often referred to as polyps or flat lesions. These benign precursors can become tumors which are initially localized (stage I or II), but over the course of the disease spread into lymph nodes (stage III) and finally metastasize to distant organs such as the liver, bones or lung (stage IV). The development from a small polyp or a flat lesion to a cancer takes an average of 5 to 10 years.

In the U.S. approximately 147,000 people are estimated to be diagnosed with colorectal cancer in 2009. In Europe, including Germany, 413,000 cases were diagnosed in 2006. The five-year survival rate for patients is about 90% if the cancer is diagnosed at an early stage while it is still localized but drops to below 10% in stage IV. Accordingly, effective population-wide screening aiming at catching the cancer in early, still asymptomatic stages is considered key in lowering the mortality from this disease.

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests on the market and in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product portfolio contains the CE-marked IVD test Epi proColon^®, the world’s first regulatory cleared molecular diagnostic test for the detection of colorectal cancer in blood that is based on the biomarker Septin9, and further proprietary DNA methylation biomarkers and IVD products at various stages of development for colorectal, lung and prostate cancer. For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Philips, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

Epigenomics legal disclaimer. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. ]]> Epi proColon Company 2009 Thu, 17 Dec 2009 00:00:00 +0100 Epigenomics AG Initiates Testing of Blood Plasma Samples from PRESEPT Study in Three Independent Clinical Laboratories http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-beginnt-messung-von-blutproben-aus-presept-studie-in-drei-unabhaengigen-klinischen-lab.html PRESEPT Study evaluates clinical performance and health economic benefit of colorectal cancer... ^mSEPT9 in plasma samples collected in the PRESEPT Study. Subject enrollment into the study at 32 clinical sites is ongoing and progressing well.
PRESEPT is a prospective multi-center, multi-national clinical research study to evaluate the performance characteristics and health economic benefit of colorectal cancer screening using the ^mSEPT9 blood test in a representative asymptomatic screening eligible population. Once completed, the PRESEPT Study will be the largest commercially sponsored colorectal cancer screening studies ever conducted.

Enrollment as of early October already exceeded 6,400 subjects among which more than three quarters of the targeted 50 colorectal cancer cases have been identified by colonoscopy. Epigenomics expects to reach its original enrollment target of around 7,500 subjects during Q4 of 2009 but will continue enrolling until the study population comprises 50 colorectal cancer cases, a target expected to be reached either in late 2009 or early 2010.

^mSEPT9 testing will be performed by three independent high-profile laboratories, namely Quest Diagnostics Incorporated headquartered in Madison, NJ, U.S.A., ARUP Laboratories, Salt Lake City, UT, USA and the Institute of Laboratory Medicine and Pathobiochemistry of Charite – Universitätsmedizin Berlin, Germany. Each has passed a rigorous quality audit as well as extensive training and qualification with the mSEPT9 assay procedure before being selected for the study. The laboratories will use the recently launched CE-marked Epi proColon test kit to detect the ^mSEPT9 biomarker in the PRESEPT blood samples for this research study. The contracted laboratories will measure the ^mSEPT9 biomarker in a combined total of about 1,500 blood plasma samples collected in the PRESEPT Study. Following a predefined statistical analysis plan this subset of the about 7,500 PRESEPT blood plasma samples will include all 50 CRC cases, several hundred cases with polyps and a random selection of about 900-1000 colonoscopy-verified subjects with no evidence of disease as controls. Following the processing of all samples, the results of ^mSEPT9 testing will be compared to the findings by colonoscopy plus the histopathology of the polyps and cancer cases by an independent biostatistical group at the University of Minnesota.

The plasma samples to be tested are being selected by the Study Principal Investigator and subject identity or clinical status are masked to the testing laboratories. Thus, throughout ^mSEPT9 testing neither Epigenomics nor its laboratory partners will know the identity of the subjects corresponding to the samples or the colonoscopy results of the respective subjects. The biostatistical group will unmask the samples and compare the results of ^mSEPT9 testing with the findings in colonoscopy after all of the ~ 1,500 blood samples are analyzed for the ^mSEPT9 biomarker.

The blood plasma samples will be processed in several batches, the first of which will be tested in the first half of October with further batches scheduled for later in October, November, and December. Testing of the last batch will commence once the 50th cancer subject is identified. Each batch will contain randomized, masked samples from cancer and polyp cases, and control subjects with no evidence of disease. After unmasking and data analysis, the Study Principal Investigator along with the PRESEPT Study independent oversight group, the Clinical Study Steering Committee, will accurately report the results of the PRESEPT Study according to the highest standards of scientific and clinical research.

Epigenomics expects that preliminary results will be available either late in 2009 or early 2010. The detailed results of the PRESEPT Study will subsequently be submitted for publication in a top-tier peer-reviewed journal and presented at major medical conferences in the first half of 2010.

“With the start of blood plasma sample testing we have reached an important milestone in the PRESEPT clinical study and have entered the home stretch for completion,” stated Cathy Lofton-Day, PhD, Project Manager of PRESEPT at Epigenomics, Inc., Seattle. “We believe that all three laboratories are excellent choices for testing the samples and generating data for mSEPT9 biomarker performance in the PRESEPT cohort,” she added.

“Choosing to go with high-quality external clinical laboratories will add significant credibility to the PRESEPT Study results and should demonstrate the robustness of our assay in routine clinical laboratory settings,” Michael Wandell, PharmD, Study Director PRESEPT, Epigenomics Inc., Seattle remarked. “We are using our Epi proColon kit to measure the PRESEPT samples. This kit has recently been CE marked and is commercially available to clinical laboratories as an IVD test kit in Europe through Epigenomics’ direct marketing and sales organization.”

Geert Nygaard, CEO of Epigenomics AG, further stated: “Demonstrating the performance of our Epi proColon IVD blood test in this prospective screening cohort will be of tremendous value to our marketing efforts in Europe and in making the Septin9 blood test a widely accepted additional option for colorectal cancer screening.”

Further Information

For further information on PRESEPT, please visit www.presept.net or clinicaltrials.gov (Identifier: NCT00855348).

More information on the partner laboratories can be found on their respective web sites:
Quest Diagnostics: www.questdiagnostics.com
ARUP Laboratories: www.aruplab.com
ZLP, Charité – Universitätsmedizin Berlin: zlp.charite.de (German)

About Epi proColon

Epi proColon is a CE-marked, in vitro diagnostic real-time PCR test kit for the qualitative detection of SEPT9 gene methylation (^mSEPT9) in cell-free bisulfite converted DNA isolated from human plasma samples. Presence of ^mSEPT9 is associated with, and may aid in, the detection of invasive colorectal adenocarcinoma.

The ^mSEPT9 assay is based on detecting aberrant DNA methylation of the v2 region of the Septin9 gene. Cytosine residues in the v2 region become methylated in colorectal cancer tissue but not in normal colon mucosa. This aberrant methylation can be detected by specific amplification of DNA shed into the blood stream by tumor cells. Detection of colorectal cancer DNA using the ^mSEPT9 biomarker has been demonstrated in multiple case control studies with plasma specimens from colorectal cancer patients and colonoscopy-verified negative controls to be a strong indicator of the presence of colorectal cancer.

For more information on Epi proColon test and its availability in Europe visit www.epiprocolon.com or contact Epigenomics directly by Email (sales@products.epigenomics.com) or phone (+49 30 24345 111).

Epi proColon is not for sale in the United States of America.

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests on the market and in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product portfolio contains Epi proColon, a CE-marked IVD blood test for the early detection of colorectal cancer based on the validated biomarker ^mSEPT9, and further proprietary DNA methylation biomarkers at various stages of development for colorectal, prostate and lung cancer detection in urine, blood and bronchial lavage specimens. Epigenomics’ biomarker ^mSEPT9 for the early detection of colorectal cancer in a simple blood sample has demonstrated continuously highest performance in eight clinical case-control studies with in total more than 3,250 individuals tested. A large prospective clinical study – PRESEPT – to evaluate the performance characteristics and the health economic benefit of colorectal cancer screening with the mSEPT9 biomarker in a representative screening population currently under way (www.presept.net). Once completed, the PRESEPT Study will be one of the largest commercially sponsored colorectal cancer screening clinical studies ever conducted. The clinical performance and health economic analysis results are expected to support future coverage of ^mSEPT9 testing by public and private health insurers worldwide. Epigenomics’ partners developing IVD test kits for the ^mSEPT9 biomarker can co-fund and access the PRESEPT sample collection to conduct clinical trials for regulatory filings in the U.S.

For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Philips, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products.

Partners in the health care industry and the biomedical research community can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established.
]]> Epi proColon Company 2009 Thu, 08 Oct 2009 00:00:00 +0200 Epigenomics AG Launches its Epi proColon Product in Europe - the First Ever In Vitro Diagnostic Blood Test for Colorectal Cancer Early Detection http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-fuehrt-sein-epi-procolon-produkt-in-europa-ein-der-erste-in-vitro-diagnostische-blut.html Epi proColon is the first CE-marked test in accordance with European IVD regulations for the early... proColon is an innovative molecular diagnostic test that can detect tumor derived methylated DNA of the Septin9 gene (^mSEPT9) in blood plasma as a reliable indicator, or biomarker, for colorectal cancer.

In a performance evaluation study, the final step of Epigenomics’ IVD product development, analyzing blood samples from about 260 patients with colorectal cancer or without any evidence of colorectal cancer, the Epi proColon test detected two thirds of the cancer cases in early, still localized disease stages. When colorectal cancer is still localized, i.e. has not spread to lymph nodes or distant organs, about 90% of the patients can be cured from the disease (90% 5-year survival rate).

Preceding the performance evaluation study and the launch of Epi proColon, Epigenomics had shown in seven clinical studies between 2005 and 2008 with a total of more than 3,000 subjects that ^mSEPT9 in blood plasma is a strong biomarker for the presence of colorectal cancer. In these studies ^mSEPT9 testing detected about 70% of the cancers across all disease stages (i.e. early as well as later stages) with about 90% specificity, results that were confirmed in the most recent performance evaluation study for the Epi proColon test.
Early detection of colorectal cancer in a simple blood draw has the potential to overcome the most challenging hurdles in colorectal screening - patient compliance.

Colorectal cancer screening in Germany is recommended by national guidelines. Under this scheme annual screening with guaiac Fecal Occult Blood Test (FOBT), a test that detects invisible blood in stool, is recommended from the age of 50 years. From 55 years and onwards an ambulant colonoscopy is recommended that should be repeated after ten years. Individuals not willing to agree to a colonoscopy are recommended to continue FOBT testing every other year. Both, guaiac FOBT and colonoscopy are reimbursed by the public healthcare scheme in Germany. Despite these recommendations the vast majority of Germans over the age of 50 are not screened at all and as a consequence colorectal cancer is mostly detected in symptomatic later stages significantly lowering the patients’ chances of survival. Lack of convenience and reservations against invasive methods are among the reasons most often cited for this lack of compliance. Other European countries and the U.S. that have comparable screening guidelines all face similar challenges.
A blood test for colorectal cancer early detection that can easily be integrated into an annual health check-up and does not require patient involvement is believed to be more acceptable to doctors and patients and has the potential to greatly increase the effectiveness of national screening programs by increasing overall screening compliance. If tested positive in such an easy-to-use blood test, patients would be referred to a gastroenterologist for colonoscopy to confirm the diagnosis and initiate early treatment.

“The big issue in colorectal cancer screening remains that far too few people make use of it. Stool tests and colonoscopy are still not sufficiently accepted by patients”, explained Dr. Thomas Roesch, Professor for Endoscopy at the University Medical Center Hamburg-Eppendorf. “In this situation a simple blood test makes a lot of sense as it is easy to use for the patients and quickly done. And who wouldn’t accept to undergo colonoscopy if the blood test already indicated a high risk of having colorectal cancer?”

The Epi proColon blood test does not only have the chance to gain better acceptance in the target group for colorectal cancer screening. With a cancer detection rate of about 70% it also significantly outperforms guaiac FOBTs, that are the currently most widely used stool tests used for screening but only find 30-40% of the cancer cases.

Epi proColon is the first CE-marked in vitro diagnostics product that Epigenomics markets directly to molecular diagnostic laboratories in Europe. Septin9 testing is currently being offered by selected innovative early adopter laboratories including Viollier AG in Switzerland and the German laboratories Krone, Limbach, MVZ Dr. Stein, and MVZ Dr. Eberhard & Partner. These labs have established and validated laboratory developed tests for the ^mSEPT9 biomarker. With the availability of Epi proColon that has been fully validated and CE-marked by Epigenomics as an aid in the detection of colorectal cancer, Septin9 testing can now be implemented in a much broader range of clinical laboratories with molecular diagnostics capabilities across Europe. Epigenomics aims at serving the home market in Germany, Austria and Switzerland through direct marketing and sales, while initially commercializing through distributors in other European markets.

“With the launch of Epi proColon we follow the request by our customers to offer a CE-marked version of our Septin9 test that can easily be implemented and takes away the burden of validation from the laboratory “, explained Geert Nygaard, Chief Executive Officer of Epigenomics. “It also marks a great leap forward in the execution of our commercial strategy to become a leading molecular diagnostics company. With Epi proColon we are the world’s first company offering a regulated IVD product for the early detection of colorectal cancer using a simple blood draw. This test has the potential to be used for population-wide colorectal cancer screening. With several hundred million people world-wide being eligible for colorectal cancer screening, our test has the potential to save many lives and at the same time addresses one of the most attractive future markets in molecular diagnostics.”

To ensure the broadest possible availability of blood-based colorectal cancer early detection, Epigenomics also pursues a non-exclusive licensing strategy and is working with partners in the diagnostics industry, including Abbott Molecular, Chicago, IL, U.S.A. and Quest Diagnostics, Giralda Farms, NJ, U.S.A., that are expected to start offering their Septin9 tests in Europe and the U.S.A., respectively, in the fourth quarter of 2009. Further partners include ARUP Laboratories, Salt Lake City, UT, U.S.A., and Sysmex Corporation, Kobe, Japan.

“With the decision for direct commercialization of Epi proColon in addition to our partnering strategy, Epigenomics will take a much more active role in building the colorectal cancer blood testing market. We intend to leverage the know-how we have gathered in colorectal cancer screening over the years as we developed the test with some of the most influential opinion leaders in the field“, Nygaard explained Epigenomics’ strategic move. “However, we continue to be fully committed to our non-exclusive partnering strategy for ^mSEPT9 and strongly believe in the synergies created by several diagnostics players advocating colorectal cancer blood testing as an alternative to current stool tests for screening and offering the test on multiple diagnostic platforms. To this end we will continue to support our current and future partners in their development and commercialization efforts for colorectal cancer blood tests based on ^mSEPT9 to the extent permitted and possible.”

Epigenomics will introduce the Epi proColon test to German laboratory physicians at the upcoming 6th Annual Conference German Society of Clinical Chemistry and Laboratory Medicine (DGKL) in Leipzig, Germany, on October 7-10, 2009 and to a broader European audience at GASTRO 2009 in London, UK, on November 21-25, 2009.

Conference Call for Investors and Media

Epigenomics’ management will host a conference call on the Epi proColon launch and its strategy going forward at 4pm CET today, Tuesday October 6, 2009. The dial-in numbers for the conference call are:

Dial-in number (within Germany): +49 (0)69 247 501 891
Dial-in number (within the US): +1 212 444 0297

Participants are kindly requested to dial in 10 minutes prior to the start of the call.

The presentation accompanying the conference call will be available at 3 pm for download on the Epigenomics website: http://www.epigenomics.com/en/down_loads/corporate_material/

A recording of the conference call will be provided on Epigenomics’ website subsequently:
http://www.epigenomics.com/en/down_loads/corporate_material/

Epigenomics at the DGKL and GASTRO Conferences

Epigenomics will be represented at the DGKL (German Society for Clinical Chemistry and Laboratory Medicine) Conference 2009 in Leipzig, Germany, from October 7th to 10th 2009, with a booth in the Congress Center Leipzig, Hall 1, booth number 17+18.

A poster presentation reporting the first experiences with the Septin9 test in daily laboratory routine will be presented by Dr. Lothar Kruska, Head of Molecular biology laboratory at MVZ Dr. Stein, Moenchengladbach, Germany, on October 8th 2009, from 3:30pm to 4:30 pm, at the Congress Center Leipzig, Hall 1, booth number 17+18.

Epigenomics will be represented at the GASTRO 2009 congress at ExCel London, UK, One Western Gateway Royal Victoria Dock, from November 21st to 25th 2009, at the industry exhibition, booth number 90.

A poster presentation titled “Clinical Performance of a blood-based test for detection of the Septin9 biomarker for colorectal cancer screening” (Poster number P0964) will be presented during the poster session “Colonic and Anorectal disorders II”, by Dr. Gunter Weiss, Vice President Product Development at Epigenomics AG, on Tuesday, November 24th, 2009, from 9 am to 5 pm, at ExCel London, Hall S10.

About Epi proColon

The Epi proColon test is a CE-marked, in vitro diagnostic real-time polymerase chain reaction (real-time PCR) test kit for the qualitative detection of SEPT9 gene methylation (^mSEPT9) in bisulfite converted DNA isolated from human plasma samples. Presence of ^mSEPT9 is associated with, and may aid in, the detection of invasive colorectal adenocarcinoma.

The ^mSEPT9 assay is based on detecting aberrant DNA methylation of the v2 region of the Septin9 gene. Cytosine residues in the v2 region become methylated in colorectal cancer tissue but not in normal colon mucosa. This aberrant methylation can be detected by specific amplification of DNA shed into the blood stream by tumor cells. Detection of colorectal cancer DNA using the ^mSEPT9 biomarker has been demonstrated in multiple case control studies with plasma specimens from colorectal cancer patients and colonoscopy-verified negative controls to be a strong indicator of the presence of colorectal cancer.

For more information on Epi proColon test and its availability in Europe visit www.epiprocolon.com or contact Epigenomics directly by Email (sales@products.epigenomics.com) or phone (+49 30 24345 111).

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests on the market and in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product portfolio contains Epi proColon, a CE-marked IVD blood test for the early detection of colorectal cancer based on the validated biomarker ^mSEPT9, and further proprietary DNA methylation biomarkers at various stages of development for colorectal, prostate and lung cancer detection in urine, blood and bronchial lavage specimens. Epigenomics’ biomarker ^mSEPT9 for the early detection of colorectal cancer in a simple blood sample has demonstrated continuously highest performance in multiple clinical studies with in total more than 3,000 individuals tested. A large prospective clinical study – PRESEPT – for evaluation of ^mSEPT9 in a screening population is currently under way (www.presept.net).

For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access.
Strategic diagnostics industry partners include Abbott Molecular, Philips, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products.

Partners in the health care industry and the biomedical research community can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established.
]]> Epi proColon Company 2009 Tue, 06 Oct 2009 00:00:00 +0200 Epigenomics AG: First Blood Test for Colorectal Cancer Available in Germany http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-erster-bluttest-fuer-darmkrebs-in-deutschland-erhaeltlich.html First diagnostic laboratories start offering testing based on Epigenomics’ Septin9 biomarker... ^mSEPT9 on October 1st, 2009. Among the first laboratories offering ^mSEPT9 testing for colorectal cancer to gastroenterologists, general practitioners, and patients in Germany will be Labor Krone (Bad Salzuflen), Labor Limbach (Heidelberg), MVZ Dr. Stein (Mönchengladbach), and MVZ Dr. Eberhard & Partner (Dortmund). The launch in Germany follows the introduction of ^mSEPT9 testing in Switzerland by the Swiss laboratory network Viollier AG on July 1st, 2009.

Epigenomics today will host a press conference on the medical utility of the ^mSEPT9 biomarker for colorectal cancer blood testing and how it may help to overcome key challenges in colorectal cancer screening effectiveness at this year’s joint Multidisciplinary Congress of ECCO – the European Cancer Organisation and
ESMO – the European Society for Medical Oncology in Berlin, Germany.

In numerous clinical studies with a total of more than 3,000 subjects Epigenomics has shown that methylated DNA of the Septin9 gene (^mSEPT9) in blood plasma is a strong indicator, or biomarker, for the presence of colorectal cancer. This has opened the way to developing tests for the early detection of colorectal cancer in a simple blood-draw addressing the most challenging hurdles in colorectal screening - patient compliance.
Colorectal cancer screening in Germany is recommended and reimbursed under the public health care scheme from the age of 50. Fecal Occult Blood Testing (FOBT), a test that detects invisible blood in stool, is recommended to patients once a year. From 55 years and onwards ambulant colonoscopy is recommended that should be repeated after ten years. Individuals not willing to agree to a colonoscopy are recommended to continue FOBT testing on a biannual schedule. Despite these recommendations the majority of Germans over the age of 50 are not screened at all and as a consequence colorectal cancer is mostly detected in symptomatic stages significantly lowering their chances of survival. Lack of convenience and reservations against invasive methods are among the reasons most often cited for this lack of compliance. Other countries with comparable screening guidelines including, the U.S., face similar challenges.

A blood test for colorectal cancer early detection that is easily integrated into an annual health check-up and does not require patient involvement is believed to be more acceptable to doctors and patients and has the potential to greatly increase the effectiveness of national screening programs. If tested positive in such an easy to use blood test, patients would be referred to a gastroenterologist for colonoscopy to confirm the diagnosis and initiate early treatment.

“Most people in Germany by now know that cancer screening is offered and also believe that this is useful and beneficial. The dilemma is that they don’t make use of it themselves“, stated Prof. Jürgen Rieman, M.D., chairman of the board of Stiftung Lebensblicke, a non-profit organization advocating colorectal cancer screening in Germany for more than ten years. “With a new and easy to use blood test we could achieve our goal of substantially increasing acceptance of and participation in colorectal cancer screening. Patients tested positive would be followed up by colonoscopy”, he continued.

“As a diagnostic laboratory with a focus on innovative molecular diagnostics, we will offer ^mSEPT9 testing to general practitioners and gastroenterologists in our network”, explained Angelika Vogel, responsible laboratory physician for molecular diagnostic testing at Labor Krone. “This test requires a standard blood draw and no further invasive procedures or patient involvement. All other steps are performed in the quality controlled environment of a professional diagnostics laboratory ensuring the highest quality and reliability of the results to the benefit of the patients and as a basis for further counseling.”

Septin9 testing is initially offered to self-payors and privately insured patients. A large prospective clinical study, PRESEPT, is underway to demonstrate the medical utility and in particular also health economic benefit in population-wide colorectal screening with the Septin9 test. The data is expected to be instrumental in achieving cancer screening guideline inclusion and eventually coverage by public health care schemes in Germany and other European countries as well as the U.S.

To ensure widespread availability of blood-based colorectal cancer early detection, Epigenomics is working with partners in the diagnostics industry, including Abbott Molecular, Chicago, IL, U.S.A. and Quest Diagnostics, Giralda Farms, NJ, U.S.A., that are expected to start offering their Septin9 tests in Europe and the U.S.A., respectively, in the fourth quarter of 2009. Further partners include ARUP Laboratories, Salt Lake City, UT, U.S.A., and Sysmex Corporation, Kobe, Japan.

Press Conference Details

The press conference titled: “A milestone in colorectal cancer screening: The detection of the biomarker mSEPT9 in a simple blood draw”, with presentations by Prof. Juergen Riemann, M.D., Chairman of the Board of Stiftung Lebensblicke, Dr. Achim Plum, Senior Vice President Corporate Development at Epigenomics AG and Angelika Vogel, Laboratory Physician at Labor Krone, will take place today, Monday, September 21st 2009, from 6:30 pm to 8:00 pm, at the ICC Berlin, Neue Kantstrasse/ Ecke Messedamm, conference room 28/29.

Poster Presentation Details

A poster presentation titled “A New Duplex Real-time PCR Assay for Detection of the ^mSEPT9 Biomarker for Colorectal Cancer Screening Using Blood Plasma” (Poster number 180) will be presented by Dr. Gunter Weiss, Vice President Product Development at Epigenomics AG, on September 22nd 2009, from 9 to 12 am, at ICC Berlin, Hall 13, booth A-21.

About Colorectal Cancer

Colorectal cancer (or colorectal carcinoma) refers to a malignant growth of the colorectal mucosa. Colorectal cancer develops usually in several phases and over many years, beginning with abnormal cell proliferation (adenoma) inside the colon and that over the time forms polyps or flat lesions. These benign precursors can become tumors which are initially localized (stage I or II), but over the course of the disease spread into lymph nodes (stage III) and finally metastasize to distant organs such as the liver, bones or lungs (stage IV). The development from a small polyp or a flat lesion to a cancer takes an average of 5 to 10 years.

In the U.S. approximately 147,000 people are estimated to be diagnosed with colorectal cancer in 2009. In Europe, including Germany, 413,000 cases were diagnosed in 2006. The five-year survival rate for patients is about 90% if the cancer is diagnosed at an early stage while it is still localized but drops to below 10% in stage IV. Accordingly, effective population-wide screening aiming at catching the cancer in early, still asymptomatic stages is considered key in lowering the mortality from this disease.

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product pipeline contains a validated biomarker for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in urine, blood and bronchial lavage specimens. Epigenomics’ biomarker ^mSEPT9 for the early detection of colorectal cancer in a simple blood sample has continuously demonstrated the highest performance in multiple clinical studies with blood samples from in total more than 3,000 individuals. A large prospective clinical study – PRESEPT – for evaluation of ^mSEPT9 in a screening population is currently under way (www.presept.net).

For development and global commercialization of in vitro diagnostic test products, Epigenomics pursues a non-exclusive partnering strategy. Strategic diagnostics industry partners include Abbott Molecular, Philips, Sysmex Corporation, Quest Diagnostics, Inc., and ARUP Laboratories, Inc. for diagnostic test products and services, and QIAGEN N.V. for sample preparation solutions and research products.

Partners in the health care industry and the biomedical research community can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 150 patent families through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established. ]]> Epi proColon Company 2009 Mon, 21 Sep 2009 00:00:00 +0200 Epigenomics AG Presents Colorectal Cancer Blood Test at ESMO Conference http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-praesentiert-bluttest-fuer-darmkrebs-auf-esmo-konferenz.html mSEPT9 biomarker facilitates innovative blood test for colorectal cancer PRESEPT Study for... Press release, Berlin, Germany, and Seattle, WA, USA, June 25, 2009 - Epigenomics AG (Frankfurt Prime Standard: ECX), a molecular diagnostics company focusing on the development and commercialization of products for cancer detection based on DNA methylation, will report on the development status and performance of its blood-based test for colorectal cancer in a poster presentation during this year’s European Society for Medical Oncology (ESMO) Conference: 11th World Congress on Gastrointestinal Cancer, in Barcelona, Spain. The European Society for Medical Oncology (ESMO) is the leading European non-profit, professional organization for medical oncology with a focus on promoting multidisciplinary cancer treatment around the world.

Epigenomics’ test, which is able to detect colorectal cancer in a simple blood draw, is based on the patented biomarker ^mSEPT9. The biomarker, which has previously been successfully tested in several case-control studies with more then 3,000 participants in total, is currently being evaluated for its utility in population wide colorectal cancer screening in the ongoing prospective PRESEPT Study.

In her presentation, Dr. Catherine Lofton-Day, Vice President Molecular Biology and project manager of the PRESEPT Study at Epigenomics, will give an overview on the extensive validation work for the mSEPT9 biomarker. In particular she will be focusing on results from two clinical case control studies with several hundred patients successfully completed in 2008 that demonstrate the performance of the ^mSEPT9 biomarker in detecting colorectal cancer in blood samples. The study results have recently been published in a peer-reviewed publication in Clinical Chemistry titled “Circulating Methylated Septin 9 DNA in Plasma is a Biomarker for Colorectal Cancer” (1).

„These two case control studies now published are the latest in a series of seven published studies with over 3,000 cancer patients and controls in which we demonstrated the underlying principle of the test, that our ^mSEPT9 assay reliably detects DNA derived from colorectal tumors in blood samples, thereby indicating the presence of colorectal cancer of all stages”, explained Dr. Lofton-Day.

Furthermore Dr. Lofton-Day will be focusing on the progress of the PRESEPT Study that is sponsored by Epigenomics. PRESEPT is a multi-center, multinational clinical study to prospectively evaluate the clinical utility of mSEPT9 testing for population-wide colorectal cancer screening. The study includes individuals at average to increased risk for colorectal cancer who have been scheduled for a screening colonoscopy. The study population of about 7,500 individuals is expected to harbor about 50 cases with undetected colorectal cancer. The results of the ^mSEPT9 blood testing, which will be performed in independent laboratories, will be compared to the results of colonoscopy - the gold standard in colorectal cancer diagnosis - to demonstrate the utility of this innovative test in colorectal cancer screening. The performance characteristics determined in the PRESEPT Study will also provide input for a health economic evaluation of ^mSEPT9 blood testing for population-wide colorectal cancer screening. It is one of the first studies ever to evaluate the performance of a non-invasive test using a standard blood draw to indicate the presence of colorectal cancer in a cohort representing the colorectal cancer screening population.

”To date we have made great progress in our PRESEPT Study and we are confident the original schedule will be kept with first results presented by the end of this year”, explained Dr. Lofton-Day. According to Dr. Lofton-Day more than 4,600 individuals have been enrolled into the study and two thirds of the 50 expected cases with previously undetected colorectal cancers have been identified.

It is anticipated that a positive outcome of the PRESEPT Study would promote rapid acceptance of this novel diagnostic method among primary care physicians and gastroenterologists as an aid in detecting early stage colorectal cancer. Epigenomics and its partners intend to launch both an in vitro diagnostic ^mSEPT9-based blood test in Europe, and laboratory developed test (LDT) in the U.S. in 2009. From July 1st 2009 onwards the European laboratory network, Switzerland based Viollier AG, will be the first clinical laboratory to begin offering ^mSEPT9-testing to patients, primary care physicians and gastroenterologists in Europe.

2009 ESMO Conference: 11th World Congress on Gastrointestinal Cancer Presentation Details

The poster, titled “Clinical Studies verify performance of the Blood-based Septin 9 DNA Methylation Assay for the Detection of Colorectal Cancer” by, Catherine Lofton-Day, Theo de Vos, Matthias Schuster, Andrew Sledziewski, Michael Wandell and Thomas Rösch will be presented at the ESMO Conference: 11th World Congress on Gastrointestinal Cancer in Barcelona, Spain on Friday, June 26, 2009, 6.15 pm – 6.45 pm at the CCIB, Exhibit Hall, by Dr. Catherine Lofton-Day, Vice President Molecular Biology and Project Manager of PRESEPT at Epigenomics.

(1) Article published online in April 2009: www.clinicalchemistry.org

A printed version will be published in Clinical Chemistry, on July 1st, 2009, Issue: 55 (7), p. 1337. Author: De Vos, T. et al; Title: “Circulating Methylated Septin 9 DNA in Plasma is a Biomarker for Colorectal Cancer”.

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product pipeline contains a validated biomarker for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in urine, blood and bronchial lavage specimens. Epigenomics’ biomarker ^mSEPT9 for the early detection of colorectal cancer in a simple blood sample has demonstrated continuously highest performance in multiple clinical studies with in total more than 3,000 individuals tested. A large prospective clinical study – PRESEPT – for evaluation of ^mSEPT9 in a screening population is currently under way (www.presept.net).

For development and global commercialization of in vitro diagnostic test products, Epigenomics pursues a non-exclusive partnering strategy. Strategic diagnostics industry partners include Abbott Molecular, Philips, Sysmex Corporation and Quest Diagnostics Incorporated for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products.

Partners in the health care industry and the biomedical research community can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 150 patent families through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established.

]]> Epi proColon Company 2009 Thu, 25 Jun 2009 00:00:00 +0200 Swiss Viollier AG First Laboratory in Europe to offer Epigenomics' Colorectal Cancer Blood Test http://www.epiprocolon.com/forum/nachrichten/article/schweizer-viollier-ag-bietet-als-erstes-diagnostiklabor-in-europa-epigenomics-bluttest-fuer-darmkreb-1.html The Swiss private diagnostic laboratory will launch mSEPT9 blood testing service for colorectal... Epigenomics AG (Frankfurt Prime Standard: ECX), a molecular diagnostics company focusing on the development and commercialization of products for cancer detection based on DNA methylation, today reports that its blood-based test for colorectal cancer will be available for the first time to patients in Europe starting from July 1, 2009. The test, which is able to detect colorectal cancer in a simple blood draw, is based on Epigenomics’ patented biomarker ^mSEPT9 and is the first blood test ever for colorectal cancer detection offered in Europe. As the first laboratory network Swiss Viollier AG will offer the test to patients, general practitioners and gastroenterologists. Viollier AG, headquartered in the Basel area, is one of Switzerland’s largest private diagnostic laboratories and an innovative leader in laboratory diagnostics.

”We are excited to be the first laboratory to work with the ^mSEPT9 test. This test is a true innovation in early cancer detection”, commented Edouard H. Viollier, MD, chairman, board of directors Viollier AG. “Blood sampling is easy and convenient for both the patient and the doctor and this test is performed in our professional laboratory under highest quality standards that ensure reliable results. We believe that this could be the future of non-invasive colorectal cancer screening and key to increasing compliance to screening programs.”

With approximately 149,000 and 300,000 newly diagnosed individuals each year in the U.S. and Europe, respectively, colorectal cancer is the most frequent gastrointestinal tumor and second in cancer mortality each year in the U.S. and Europe. With approximately 4,100 new cases every year Switzerland is the country with the highest colorectal cancer incidence in Europe. In total 10.4% of all cancer-related deaths in Switzerland are caused by colorectal cancer.

The majority of colorectal cancers are diagnosed in advanced stages, limiting the chances for curative treatment. To improve prognosis for this disease the cancer must be detected in early stages. More than 90% of all patients could be cured if the cancer was diagnosed at an early, still localized stage.

Many countries including the U.S. and Germany introduced colonoscopy - typically in ten year intervals - as a screening modality for colorectal cancer. In Switzerland, although no national colorectal cancer screening program was introduced yet, colonoscopy is recommended from the age of 50 by private and public cancer prevention initiatives. By these screening programs and initiatives, the detection of colorectal cancer in early disease stages was expected to improve considerably. However, only a minority of the target population complies with screening recommendations, hence limiting the success of these approaches. Time requirements, invasiveness and fear of complications prevent most individuals from undergoing this sensible screening procedure. Besides colonoscopy, non-invasive tests for the detection of blood in stool samples (Fecal Occult Blood Test – FOBT) are currently recommended as a screening modality. However, they are not well accepted by patients because they have to be performed by the patients themselves and certain nutritional recommendations have to be followed. A blood-based test, detecting early stages of colorectal cancer because of its convenience for patients and doctors could encourage people, who reject colonoscopy and stool tests, to participate in colorectal cancer screening programs. An endoscopic examination would be strongly recommended particularly to those patients with a positive finding in the blood test.

“Compliance is the biggest hurdle in colorectal cancer screening. Although there are procedures like colonoscopy and FOBT that have been established as screening modalities for several years now, there still is very little acceptance and poor compliance by the patients”, Prof. Peter Bauerfeind, of the Division of Gastroenterology & Hepatology of the University Hospital Zurich, Switzerland, commented the launch of the test. “A blood-based test fits into doctors’ daily routine and requires almost no patient involvement. Such a test for colorectal cancer screening could find much better acceptance among patients and drive compliance.”

The ^mSEPT9 colorectal cancer blood test is designed to be as convenient and patient friendly as possible. All it takes for the patient is giving a blood sample in the doctor’s office as part of their regular check-up. The sample is shipped to a local or regional diagnostic laboratory where it is tested for the ^mSEPT9 biomarker. The test result is provided to the doctor who can discuss it with the patient within a few days after the blood sample was taken. If the test were positive, a colonoscopy would typically be performed to confirm the test result and localize the tumor as a first step towards cancer therapy.
Epigenomics has shown in a series of seven published case control studies with over 3,000 patient-samples and controls, that the ^mSEPT9 assay reliably detects cell–free DNA derived from colorectal tumors in blood samples and thereby indicates the presence of colorectal cancer of all stages.

Epigenomics expects further diagnostic laboratories in Europe to introduce ^mSEPT9 testing in due course. In addition, Epigenomics’ non-exclusively licenses the ^mSEPT9 biomarker and its technologies to partners in the diagnostics industry for global commercialization of in vitro diagnostic blood tests for colorectal cancer based on ^mSEPT9. A first IVD test kit for ^mSEPT9 testing is expected to be launched in Europe by the end of 2009. In the U.S., ^mSEPT9 testing is expected to be offered initially by Quest Diagnostics, a leader in diagnostic testing, information and services in the U.S. Quest Diagnostics is currently in the process of establishing a laboratory-developed test for ^mSEPT9 under license from Epigenomics. FDA approved IVD products through Epigenomics’ current and future IVD partners will follow.

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product pipeline contains a validated biomarker for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in urine, blood and bronchial lavage specimens. Epigenomics’ biomarker ^mSEPT9 for the early detection of colorectal cancer in a simple blood sample has demonstrated continuously highest performance in multiple clinical studies with in total more than 3,000 individuals tested. A large prospective clinical study – PRESEPT – for evaluation of ^mSEPT9 in a screening population is currently under way (www.presept.net).

For development and global commercialization of in vitro diagnostic test products, Epigenomics pursues a non-exclusive partnering strategy. Strategic diagnostics industry partners include Abbott Molecular, Philips, Sysmex Corporation and Quest Diagnostics Incorporated, for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products.

Partners in the health care industry and the biomedical research community can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 150 patent families through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established.

]]> Epi proColon Company 2009 Tue, 23 Jun 2009 00:00:00 +0200 Epigenomics AG Reports PRESEPT Clinical Study Progress http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-macht-fortschritte-bei-presept-studie.html Successfully qualified 17 PRESEPT clinical sites; 12 sites initiated Enrollment nearly...
Since starting the PRESEPT Study in Q2 of 2008, Epigenomics has successfully qualified 17 clinical sites, 12 of which have been initiated, enrolling nearly 500 subjects in the first three months. The increased number of clinical sites is expected to now rapidly ramp up accrual of subjects over the next several months.

When the total of up to 20 clinical sites including three in Germany are initiated, PRESEPT will be one of the largest commercially sponsored colorectal cancer screening clinical studies ever conducted. Epigenomics is providing clinical collaborators, medical professionals, and the interested public with study details and regular updates on the progess of the PRESEPT Study on the recently launched website www.presept.net.

Among those clinical sites recently added to the PRESEPT Study was the first German investigator, Dr. Alireza Aminalai, in Berlin, Germany. Dr. Aminalai is a member of the Berlin Endoscopy Study Team (BEST), a regional group of gastroenterologists with a clinical research interest in gastrointestinal disorders. The BEST group is affiliated with the regional organization of private practice gastroenterologists, which also promotes initiatives of physicians in the Berlin area with the goal to enhance awareness for colorectal cancer and to promote screening.

”German gastroenterologists are determined to reduce mortality of colorectal cancer by half in the forseeable future. This goal can only be reached by the implementation of additional screening methods complementing the current gold standard of colonscopy. I am therefore pleased to join the network of PRESEPT investigators to evaluate a new approach for colorectal cancer screening. We have the sincere hope that a blood-based test could bring more people to accept colorectal screening who may not primarily opt for colonoscopy but would accept to undergo colonoscopy for definite diagnosis when tested positive”, Dr. Aminalai explained the rationale behind his support of the PRESEPT Study.

The research activites of the BEST group, which has successfully conducted several colorectal cancer studies in the past, are coordinated by Prof. Dr. Thomas Rösch, Director of the Clinic for Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf and newly appointed member of the PRESEPT Clinical Study Steering Committee.

“I am excited to join the PRESEPT Clinical Study Steering Committee and participate in this extremely important initiative. The availability of a simple, convenient blood test for colorectal cancer screening has the potential to significantly improve patient compliance, and as a result increase survival due to early detection of disease”, stated Prof. Rösch, “and including German sites into the PRESEPT Study will make overall study results even more compelling to European gastroenterologists.”

In its most recent meeting in Chicago, IL, USA on 23 October 2008, the CSSC strongly advised the study’s sponsor, Epigenomics, not to undertake an interim analysis of clinical results in early 2009, but rather to only conduct a final analysis when enrollment is complete. The Committee recommended this course to strengthen the overall study design by avoiding the statistical penalty on the study’s overall power incurred by conducting an interim analysis.

”Given the relatively short period between a possible interim analysis in H1 2009 and the final analysis planned for H2 2009, the study would incur a statistical penalty associated with the interim analysis without clear scientific benefit”, reported Committee Chairman, David Ransohoff. “We established the Committee to provide us oversight, study design advice and independent analysis, and we will heed their recommendation. We all believe that the final results of the PRESEPT Study will be that much stronger for it,” commented Michael Wandell, Pharm.D., Epigenomics’ PRESEPT Study Director. “We have made excellent progress in study execution and we believe the Committee’s advice is the correct course, even if it means our first look at the results will not occur until a little later in 2009.”

Epigenomics assembled and empowered the Clinical Study Steering Committee (CSSC) to advise the sponsor on the PRESEPT Study design, oversee the quality of the study conduct according to worldwide clinical research practice standards, and independently analyze and accurately report the results. The CSSC is chaired by David Ransohoff, MD, Professor of Medicine, Cancer Epidemiology, Cancer Prevention and Control, University of North Carolina School of Medicine, and its members include Neal Osborn, MD, Co-Director of Clinical Research, Atlanta Gastroenterology; Timothy R. Church, PhD Professor, School of Public Health, University of Minnesota; Brent Blumenstein, PhD, Principal, Trial Architecture Consulting; Dale Snover, MD, Adjunct Professor, Department of Laboratory Medicine and Pathology, University of Minnesota Medical School; Robert Day, MD, PhD, President Emeritus of The Fred Hutchinson Cancer Research Center (ex officio); and Prof. Dr. Thomas Rösch, Director of the Clinic for Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf. In addition to the external participants, two sponsor representatives, Michael Wandell, PharmD, Study Director and Cathy Lofton-Day, PhD, Project Manager, are CSSC members.

About PRESEPT

PRESEPT is a multinational, multi-center clinical study sponsored by Epigenomics to prospectively evaluate the clinical performance of Epigenomics’ proprietary biomarker, Septin 9, for colorectal cancer population screening in guideline-eligible individuals. It is one of the first studies ever to evaluate the performance of a noninvasive test to indicate the presence of colorectal cancer in asymptomatic individuals in a standard blood sample. The study is designed to enroll up to 7,500 asymptomatic subjects aged 50 or older at average to increased risk for colorectal cancer who have been scheduled for a regular screening colonoscopy at up to 20 clinical sites in the U.S. and Germany. This population is expected to harbor about 50 cases with undetected colorectal cancer.

The study is intended to characterize the performance characteristics and evaluate the health economic benefit of the Septin 9 marker with the goal to demonstrate it will meet the requirements of current U.S. screening guidelines for non-invasive screening tests. The clinical performance and health economic analysis results are expected to support future coverage by public and private health insurers worldwide. Further, Epigenomics will provide industry partners developing Septin 9 IVD tests access to the PRESEPT samples and data to perform pivotal clinical trials necessary to obtain regulatory approvals. For more information and regular updates please visit www.presept.net.

About Colorectal Cancer Screening

Colorectal cancer is the second leading cause of cancer related death in the U.S. with an estimated direct medical treatment cost of $8.3 billion in 2007. With a cure rate of over 90% if diagnosed in early stages in the United States, there is now general agreement that average-risk adults aged 50 and older should be screened for colorectal cancer. If detected early, individual treatment costs for colon cancer are estimated at $30,000 per patient, whereas treatment for a patient who has developed late stage disease is estimated at $120,000. However, less than 50% of the screening population has had a recent test. Given today’s treatment options for colorectal cancer, patient outcomes could potentially be greatly improved if more cancers were detected in early stages.

However, from a public health as well as health economics perspectives, the poor adoption of current screening options limits the effectiveness of colorectal cancer screening initiatives; Current colorectal cancer screening guidelines include two types of tests, those that detect polyps and cancer such as colonoscopy and virtual colonoscopy and those that detect cancer such as the non-invasive stool based tests. Non-invasive screening is most often conducted using FOBT, which while inexpensive, exhibits a low compliance rate due to its use restrictions, perceived inconvenience and lack of consumer acceptance. The gold standard procedure for colorectal cancer detection is colonoscopy; it exhibits excellent performance characteristics, but has a limited utility as a first line screen due to its high cost, healthcare delivery resource limitations, and inadequate patient acceptance. It is believed a noninvasive, convenient, blood-based screening assay capable of detecting individuals with colorectal disease, confirmed by colonoscopy, would have greater utility for population screening.

About the Septin 9 Biomarker

The Septin 9 gene encodes a protein involved in cell division and is thought to play a role in the onset of cancer. Epigenomics has demonstrated in multiple clinical case control studies with about 3,500 samples from colorectal cancer patients, healthy controls, and patients with non-cancerous colon diseases that methylated DNA of the Septin 9 gene shed by tumors into the blood stream can serve as a biomarker for the sensitive and specific detection of colorectal cancer. As a first strategic partner, Abbott Molecular, Inc. licensed the worldwide non-exclusive IVD rights to Epigenomics’ proprietary Septin 9 biomarker for colorectal cancer. In addition, Quest Diagnostics Inc., the leading provider of diagnostic testing, information and services, obtained the license to commercialize a laboratory-developed test (LDT) for Septin 9 in the U.S.

About DNA Methylation

DNA methylation is a natural and tightly controlled biological process that serves the regulation of genes and the stability of the human genome. Cytosine, one of the four bases in DNA, can be modified by the covalent addition of a methyl group. DNA methylation in gene regulatory regions (i.e. gene promoters) helps to control gene activity. Every cell type has its unique DNA methylation “fingerprint” that changes in various normal biological processes and in many diseases, in particular cancer. DNA methylation thus provides a rich source for highly specific biomarkers for organ-specific disease diagnosis, classification and prediction for therapeutic intervention.

About Epigenomics AG

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product pipeline contains a validated biomarker for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in urine, blood and bronchial lavage specimens. Epigenomics’ biomarker Septin 9 for the early detection of colorectal cancer in a simple blood sample demonstrated continuously highest performance in multiple clinical studies with in total about 3,500 individuals tested.

For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry companies. As a first strategic partner, Abbott Molecular Inc. licensed the worldwide non-exclusive IVD rights to Epigenomics’ proprietary Septin 9 biomarker for colorectal cancer. Epigenomics also aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. As a first reference laboratory partner, Quest Diagnostics Inc., the leading provider of diagnostic testing, information and services, obtained the license to commercialize a laboratory-developed test (LDT) for Septin 9 in the U.S.

Partners in the health care industry and the biomedical research community can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 150 patent families through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

###

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. ]]> Epi proColon Company 2008 Mon, 27 Oct 2008 00:00:00 +0100 Epigenomics AG Reports PRESEPT Clinical Study Progress http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-macht-fortschritte-bei-presept-studie-1.html Successfully qualified 17 PRESEPT clinical sites; 12 sites initiated Enrollment nearly 500... Epigenomics AG (Frankfurt, Prime Standard: ECX), a cancer molecular diagnostics company developing tests based on DNA methylation, today reported the PRESEPT Clinical Study Steering Committee had reviewed the substantial progress that has been made in the execution of the PRESEPT Study. In addition, Dr. Timothy Church has been assigned responsibility for study results analysis and Prof. Dr. Thomas Rösch has been added to the Committee as representative of the German sites.

Since starting the PRESEPT Study in Q2 of 2008, Epigenomics has successfully qualified 17 clinical sites, 12 of which have been initiated, enrolling nearly 500 subjects in the first three months. The increased number of clinical sites is expected to now rapidly ramp up accrual of subjects over the next several months.

When the total of up to 20 clinical sites including three in Germany are initiated, PRESEPT will be one of the largest commercially sponsored colorectal cancer screening clinical studies ever conducted. Epigenomics is providing clinical collaborators, medical professionals, and the interested public with study details and regular updates on the progess of the PRESEPT Study on the recently launched website www.presept.net.

Among those clinical sites recently added to the PRESEPT Study was the first German investigator, Dr. Alireza Aminalai, in Berlin, Germany. Dr. Aminalai is a member of the Berlin Endoscopy Study Team (BEST), a regional group of gastroenterologists with a clinical research interest in gastrointestinal disorders. The BEST group is affiliated with the regional organization of private practice gastroenterologists, which also promotes initiatives of physicians in the Berlin area with the goal to enhance awareness for colorectal cancer and to promote screening.

”German gastroenterologists are determined to reduce mortality of colorectal cancer by half in the forseeable future. This goal can only be reached by the implementation of additional screening methods complementing the current gold standard of colonscopy. I am therefore pleased to join the network of PRESEPT investigators to evaluate a new approach for colorectal cancer screening. We have the sincere hope that a blood-based test could bring more people to accept colorectal screening who may not primarily opt for colonoscopy but would accept to undergo colonoscopy for definite diagnosis when tested positive”, Dr. Aminalai explained the rationale behind his support of the PRESEPT Study.

The research activites of the BEST group, which has successfully conducted several colorectal cancer studies in the past, are coordinated by Prof. Dr. Thomas Rösch, Director of the Clinic for Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf and newly appointed member of the PRESEPT Clinical Study Steering Committee.

“I am excited to join the PRESEPT Clinical Study Steering Committee and participate in this extremely important initiative. The availability of a simple, convenient blood test for colorectal cancer screening has the potential to significantly improve patient compliance, and as a result increase survival due to early detection of disease”, stated Prof. Rösch, “and including German sites into the PRESEPT Study will make overall study results even more compelling to European gastroenterologists.”

In its most recent meeting in Chicago, IL, USA on 23 October 2008, the CSSC strongly advised the study’s sponsor, Epigenomics, not to undertake an interim analysis of clinical results in early 2009, but rather to only conduct a final analysis when enrollment is complete. The Committee recommended this course to strengthen the overall study design by avoiding the statistical penalty on the study’s overall power incurred by conducting an interim analysis.

”Given the relatively short period between a possible interim analysis in H1 2009 and the final analysis planned for H2 2009, the study would incur a statistical penalty associated with the interim analysis without clear scientific benefit”, reported Committee Chairman, David Ransohoff. “We established the Committee to provide us oversight, study design advice and independent analysis, and we will heed their recommendation. We all believe that the final results of the PRESEPT Study will be that much stronger for it,” commented Michael Wandell, Pharm.D., Epigenomics’ PRESEPT Study Director.. “We have made excellent progress in study execution and we believe the Committee’s advice is the correct course, even if it means our first look at the results will not occur until a little later in 2009.”

Epigenomics assembled and empowered the Clinical Study Steering Committee (CSSC) to advise the sponsor on the PRESEPT Study design, oversee the quality of the study conduct according to worldwide clinical research practice standards, and independently analyze and accurately report the results. The CSSC is chaired by David Ransohoff, MD, Professor of Medicine, Cancer Epidemiology, Cancer Prevention and Control, University of North Carolina School of Medicine, and its members include Neal Osborn, MD, Co-Director of Clinical Research, Atlanta Gastroenterology; Timothy R. Church, PhD Professor, School of Public Health, University of Minnesota; Brent Blumenstein, PhD, Principal, Trial Architecture Consulting; Dale Snover, MD, Adjunct Professor, Department of Laboratory Medicine and Pathology, University of Minnesota Medical School; Robert Day, MD, PhD, President Emeritus of The Fred Hutchinson Cancer Research Center (ex officio); and Prof. Dr. Thomas Rösch, Director of the Clinic for Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf. In addition to the external participants, two sponsor representatives, Michael Wandell, PharmD, Study Director and Cathy Lofton-Day, PhD, Project Manager, are CSSC members.

About PRESEPT

PRESEPT is a multinational, multi-center clinical study sponsored by Epigenomics to prospectively evaluate the clinical performance of Epigenomics’ proprietary biomarker, Septin 9, for colorectal cancer population screening in guideline-eligible individuals. It is one of the first studies ever to evaluate the performance of a noninvasive test to indicate the presence of colorectal cancer in asymptomatic individuals in a standard blood sample. The study is designed to enroll up to 7,500 asymptomatic subjects aged 50 or older at average to increased risk for colorectal cancer who have been scheduled for a regular screening colonoscopy at up to 20 clinical sites in the U.S. and Germany. This population is expected to harbor about 50 cases with undetected colorectal cancer.

The study is intended to characterize the performance characteristics and evaluate the health economic benefit of the Septin 9 marker with the goal to demonstrate it will meet the requirements of current U.S. screening guidelines for non-invasive screening tests. The clinical performance and health economic analysis results are expected to support future coverage by public and private health insurers worldwide. Further, Epigenomics will provide industry partners developing Septin 9 IVD tests access to the PRESEPT samples and data to perform pivotal clinical trials necessary to obtain regulatory approvals. For more information and regular updates please visit www.presept.net.

About Colorectal Cancer Screening

Colorectal cancer is the second leading cause of cancer related death in the U.S. with an estimated direct medical treatment cost of $8.3 billion in 2007. With a cure rate of over 90% if diagnosed in early stages in the United States, there is now general agreement that average-risk adults aged 50 and older should be screened for colorectal cancer. If detected early, individual treatment costs for colon cancer are estimated at $30,000 per patient, whereas treatment for a patient who has developed late stage disease is estimated at $120,000. However, less than 50% of the screening population has had a recent test. Given today’s treatment options for colorectal cancer, patient outcomes could potentially be greatly improved if more cancers were detected in early stages.

However, from a public health as well as health economics perspectives, the poor adoption of current screening options limits the effectiveness of colorectal cancer screening initiatives; Current colorectal cancer screening guidelines include two types of tests, those that detect polyps and cancer such as colonoscopy and virtual colonoscopy and those that detect cancer such as the non-invasive stool based tests. Non-invasive screening is most often conducted using FOBT, which while inexpensive, exhibits a low compliance rate due to its use restrictions, perceived inconvenience and lack of consumer acceptance. The gold standard procedure for colorectal cancer detection is colonoscopy; it exhibits excellent performance characteristics, but has a limited utility as a first line screen due to its high cost, healthcare delivery resource limitations, and inadequate patient acceptance. It is believed a noninvasive, convenient, blood-based screening assay capable of detecting individuals with colorectal disease, confirmed by colonoscopy, would have greater utility for population screening.

About the Septin 9 Biomarker

The Septin 9 gene encodes a protein involved in cell division and is thought to play a role in the onset of cancer. Epigenomics has demonstrated in multiple clinical case control studies with about 3,500 samples from colorectal cancer patients, healthy controls, and patients with non-cancerous colon diseases that methylated DNA of the Septin 9 gene shed by tumors into the blood stream can serve as a biomarker for the sensitive and specific detection of colorectal cancer. As a first strategic partner, Abbott Molecular, Inc. licensed the worldwide non-exclusive IVD rights to Epigenomics’ proprietary Septin 9 biomarker for colorectal cancer. In addition, Quest Diagnostics Inc., the leading provider of diagnostic testing, information and services, obtained the license to commercialize a laboratory-developed test (LDT) for Septin 9 in the U.S.

About DNA Methylation

DNA methylation is a natural and tightly controlled biological process that serves the regulation of genes and the stability of the human genome. Cytosine, one of the four bases in DNA, can be modified by the covalent addition of a methyl group. DNA methylation in gene regulatory regions (i.e. gene promoters) helps to control gene activity. Every cell type has its unique DNA methylation “fingerprint” that changes in various normal biological processes and in many diseases, in particular cancer. DNA methylation thus provides a rich source for highly specific biomarkers for organ-specific disease diagnosis, classification and prediction for therapeutic intervention.

About Epigenomics AG

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product pipeline contains a validated biomarker for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in urine, blood and bronchial lavage specimens. Epigenomics’ biomarker Septin 9 for the early detection of colorectal cancer in a simple blood sample demonstrated continuously highest performance in multiple clinical studies with in total about 3,500 individuals tested.

For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry companies. As a first strategic partner, Abbott Molecular Inc. licensed the worldwide non-exclusive IVD rights to Epigenomics’ proprietary Septin 9 biomarker for colorectal cancer. Epigenomics also aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. As a first reference laboratory partner, Quest Diagnostics Inc., the leading provider of diagnostic testing, information and services, obtained the license to commercialize a laboratory-developed test (LDT) for Septin 9 in the U.S.

Partners in the health care industry and the biomedical research community can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 150 patent families through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

###

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

]]> Epi proColon Company 2008 Mon, 27 Oct 2008 00:00:00 +0100 Epigenomics AG Receives Allowance for Key Patent in Europe http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-europaeisches-patentamt-gibt-gruenes-licht-fuer-schluesselpatent.html Patent covers biomarker Septin 9 for colorectal cancer screening and diagnosis Berlin, Germany, and...
Following the receipt of the patent allowance Geert Nygaard, Epigenomics’ Chief Executive Officer, commented: “This allowance marks a major milestone in our commercial strategy and company development. The patent adds a strong layer of protection to our colorectal cancer screening product and entitles us to significant royalties in years to come from our diagnostics partnerships for this biomarker.”

“Our patent protection is now not only covering our preanalytics and sensitive detection technologies such as Heavy Methyl (HM) and MethyLight proprietary, but also the core of the product, the Septin 9 biomarker, for the detection of colorectal cancer in blood”, adds Dr. Kurt Berlin, Epigenomics’ Chief Scientific Officer. “This is one of several dozen biomarker patent applications covering hundreds of proprietary DNA methylation biomarkers in many cancer indications. This patent portfolio underscores our leading position in molecular diagnostics based on DNA methylation.”

About Colorectal Cancer Screening

Colorectal cancer is the second leading cause of cancer related death in the U.S. with an estimated direct medical treatment cost of $8.3 billion in 2007. With a cure rate over 90% if diagnosed in early stages in the United States, there is now general agreement that average-risk adults aged 50 and older should be screened for colorectal cancer. If detected early, individual treatment costs for colon cancer are estimated at $30,000 per patient, whereas treatment for a patient who has developed late stage disease is estimated at $120,000. However, less than 50% of the screening population has had a recent test. Given today’s treatment options for colorectal cancer, patient outcomes could potentially be greatly improved if more cancers were detected in early stages.

However, from public health as well as health economics perspectives, the poor adoption of current screening options limits the effectiveness of colorectal cancer screening initiatives; Current colorectal cancer screening guidelines include FOBT, sigmoidoscopy (alone or with FOBT), or colonoscopy. Non-invasive screening is conducted using FOBT, which while inexpensive, exhibits a low compliance rate (around 14% in the US) due to its use restrictions, perceived inconvenience and lack of consumer acceptance. The gold standard procedure for colorectal cancer detection is colonoscopy; it exhibits excellent performance characteristics, but has a limited utility as a first line screen due to its high cost, healthcare delivery resource limitations, and inadequate patient acceptance. It is believed a noninvasive, first-line screening assay capable of detecting individuals with colorectal disease, confirmed by colonoscopy, would have greater utility for population screening.

About the Septin 9 Biomarker

The Septin 9 gene encodes a protein involved in cell division and is thought to play a role in the onset of cancer. Epigenomics has demonstrated in multiple clinical case control studies with over 3,500 samples from colorectal cancer patients, healthy controls, and patients with non-cancerous colon diseases that methylated DNA of the Septin 9 gene shed by tumors into the blood stream can serve as a biomarker for the sensitive and specific detection of colorectal cancer. As a first strategic partner, Abbott Molecular, Inc. licensed the worldwide non-exclusive IVD rights to Epigenomics’ proprietary Septin 9 biomarker for colorectal cancer. In addition, Quest Diagnostics Inc., the leading provider of diagnostic testing, information and services, obtained the license to commercialize a laboratory-developed test (LDT) for Septin 9 in the U.S.

About Epigenomics AG

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product pipeline contains a validated biomarker for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in body fluids. Epigenomics’ biomarker Septin 9 for the early detection of colorectal cancer in a simple blood sample demonstrated continuously highest performance in multiple clinical studies with in total more than 3,500 individuals tested.

For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry companies. As a first strategic partner, Abbott Molecular Inc. licensed the worldwide non-exclusive IVD rights to Epigenomics’ proprietary Septin 9 biomarker for colorectal cancer. Epigenomics also aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. As a first reference laboratory partner, Quest Diagnostics Inc., the leading provider of diagnostic testing, information and services, obtained the license to commercialize a laboratory-developed test (LDT) for Septin 9 in the U.S.

Partners in the health care industry and the biomedical research community can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 150 patent families through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

###

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
]]> Epi proColon Company 2008 Tue, 29 Jul 2008 00:00:00 +0200 First Subjects Enrolled in Epigenomics sponsored PRESEPT Colorectal Cancer Screening Study http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-startet-darmkrebsvorsorge-studie-presept.html Multi-center study in U.S. and Germany enrolling up to 7,500 individuals aims at demonstrating the... Epigenomics AG (Frankfurt Prime Standard: ECX), a molecular diagnostics company focusing on the development and commercialization of products for cancer detection based on DNA methylation, today announced the enrollment of the first subjects in the PRESEPT study.

“We are excited that our PRESEPT study is now well under way as scheduled. PRESEPT is a unique endeavor: It is one of the largest colorectal cancer screening studies ever, and is the first to prospectively evaluate a molecular marker for blood-based colorectal cancer screening”, commented Geert Nygaard, Chief Executive Officer of Epigenomics. “The study will support the imminent clinical validation and commercial launch of our partners’ diagnostics tests based on our biomarker and technology. The PRESEPT study is a great leap forward in the realization of our vision of detecting cancers based on DNA methylation patterns with a standard blood test.”

PRESEPT is a multi-center, multi-national clinical study sponsored by Epigenomics prospectively evaluating the clinical performance of Epigenomics’ proprietary biomarker, Septin 9, for colorectal cancer population wide screening of guideline-eligible individuals. With the data generated in the PRESEPT study, Epigenomics intends to demonstrate that colorectal cancer early detection with a blood test based on Septin 9 will meet the requirements of current U.S. screening guidelines for non-invasive screening tests. To support future coverage by health insurers, the performance characteristics established in PRESEPT will be used to determine the potential health economic benefit of blood based colorectal cancer screening using a validated model developed by Uri Ladabaum, M.D., M.S., University of California, San Francisco, CA. Further, Epigenomics will provide industry partners developing Septin 9 IVD tests access to the PRESEPT samples and data to perform pivotal clinical trials necessary to obtain regulatory approvals.

The study is planned to enroll up to 7,500 asymptomatic subjects with average to increased risk for colorectal cancer aged 50 or older that are scheduled for a regular screening colonoscopy at 12 to 14 clinical sites in the U.S. and Germany. This population is expected to harbor about 50 cases of undetected colorectal cancer. For each subject, blood samples are collected prior to bowel prep for colonoscopy and analyzed for methylated Septin 9 DNA by Epigenomics’ partner Quest Diagnostics. The results of Septin 9 testing are compared to the data obtained by colonoscopy, the gold standard for definitive colorectal cancer diagnosis. For the cases where polyps or cancerous lesions are identified during colonoscopy, further clinical and pathological data will be included in the classification of disease.

As a first site participating in PRESEPT, the Regional Gastroenterology Associates, Lancaster, PA, with site principal investigator Dr. Raymond Foley, began enrolling subjects last week. Further sites in the U.S. and Germany are planned to be initiated in the next few weeks. Enrollment is scheduled to ramp up to yield sufficient subjects for an interim analysis in Q1 2009. The final results of PRESEPT are expected during H2 2009.

In accordance with FDA guidance, Epigenomics established a Clinical Study Steering Committee to oversee the study and assure that it is conducted according to all applicable ethical and quality standards. The committee is chaired by David Ransohoff, M.D., University of North Carolina School of Medicine, Chapel Hill, NC. Other members of the committee include Neal K. Osborn, M.D., M.Sc., and Timothy R. Church, Ph.D., principal investigators for PRESEPT at Atlanta Gastroenterology, Atlanta, GA and the University of Minnesota, Minneapolis, MN, respectively, and Robert W. Day, M.D., Ph.D. President Emeritus of The Fred Hutchinson Cancer Research Center, Seattle, WA. Also, Brent Blumenstein, Ph.D., of Trial Architecture Consulting, Seattle, WA, was assigned as independent biostatistician. Epigenomics will be represented on the committee by the PRESEPT Study Director, Michael Wandell, Pharm.D., Senior Vice President Regulatory & Quality, and Cathy Lofton-Day, Ph.D., Vice President Molecular Biology and PRESEPT Project Manager.

"Adherence to current colorectal cancer screening options poses one of the greatest challenges to colorectal cancer detection and treatment. An effective colorectal cancer blood test that could be integrated into the routine physical examination by the primary care physician could greatly increase disease detection in asymptomatic patients. The performance demonstrated for the Septin 9 biomarker in previous case control studies warrants a thorough, in depth, and independent analysis of its potential as screening biomarker, and Epigenomics is putting in motion the elements to make this happen", explained Prof. David Ransohoff, M.D., PRESEPT Clinical Study Steering Committee Chair.

The design of the PRESEPT study was developed in close collaboration with Epigenomics’ Medical Advisory Board for Colorectal Cancer Screening that represents a cross section of primary care physicians and gastroenterologists with particular expertise in colonoscopy, colorectal cancer screening, evidence-based medicine, outcomes research, and health economic analysis.

About Colorectal Cancer Screening

Colorectal cancer is the second leading cause of cancer related death in the U.S. with an estimated direct medical treatment cost of $8.3 billion in 2007. With a cure rate over 90% if diagnosed in early stages in the United States, there is now general agreement that average-risk adults aged 50 and older should be screened for colorectal cancer. If detected early, individual treatment costs for colon cancer are estimated at $30,000 per patient, whereas treatment for a patient who has developed late stage disease is estimated at $120,000. However, less than 50% of the screening population has had a recent test. Given today’s treatment options for colorectal cancer, patient outcomes could potentially be greatly improved if more cancers were detected in early stages.

From a public health as well as a health economics perspective, the poor adoption of current screening options limits the effectiveness of colorectal cancer screening initiatives; Current colorectal cancer screening guidelines include two types of tests, those that detect polyps and cancer such as colonoscopy and virtual colonoscopy and those that detect cancer such as the non-invasive stool based tests. Non-invasive screening is most often conducted using FOBT, which while inexpensive, exhibits a low compliance rate (around 14% in the US) due to its use restrictions, perceived inconvenience and lack of consumer acceptance. The gold standard procedure for colorectal cancer detection is colonoscopy; it exhibits excellent performance characteristics, but has a limited utility as a first line screen due to its high cost, healthcare delivery resource limitations, and inadequate patient acceptance. It is believed a non-invasive, convenient, blood-based screening assay capable of detecting individuals with colorectal disease, confirmed by colonoscopy, would have greater utility for population screening.

About the Septin 9 Biomarker

The Septin 9 gene encodes a protein involved in cell division and is thought to play a role in the onset of cancer. Epigenomics has demonstrated in multiple clinical case control studies with over 3,500 samples from colorectal cancer patients, healthy controls, and patients with non-cancerous colon diseases that methylated DNA of the Septin 9 gene shed by tumors into the blood stream can serve as a biomarker for the sensitive and specific detection of colorectal cancer. As a first strategic partner, Abbott Molecular, Inc. licensed the worldwide non-exclusive IVD rights to Epigenomics’ proprietary Septin 9 biomarker for colorectal cancer. In addition, Quest Diagnostics Inc., the leading provider of diagnostic testing, information and services, obtained the license to commercialize a laboratory-developed test (LDT) for Septin 9 in the U.S.

About DNA Methylation

DNA methylation is a natural and tightly controlled biological process that serves the regulation of genes and the stability of the human genome. Cytosine, one of the four bases in DNA, can be modified by the covalent addition of a methyl group. DNA methylation in gene regulatory regions (i.e. gene promoters) helps control gene activity. Every cell type has its unique DNA methylation “fingerprint” that changes in various normal biological processes and in many diseases, in particular cancer. DNA methylation thus provides a rich source for highly specific biomarkers for organ-specific disease diagnosis, classification and prediction for therapeutic intervention.

About Epigenomics AG

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics’ product pipeline contains a validated biomarker for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in body fluids. Epigenomics’ biomarker Septin 9 for the early detection of colorectal cancer in a simple blood sample demonstrated continuously highest performance in multiple clinical studies with in total more than 3,500 individuals tested.

For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry companies. As a first strategic partner, Abbott Molecular Inc. licensed the worldwide non-exclusive IVD rights to Epigenomics’ proprietary Septin 9 biomarker for colorectal cancer. Epigenomics also aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. As a first reference laboratory partner, Quest Diagnostics Inc., the leading provider of diagnostic testing, information and services, obtained the license to commercialize a laboratory-developed test (LDT) for Septin 9 in the U.S.

Partners in the health care industry and the biomedical research community can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 150 patent families through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

###

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

]]> Epi proColon Company 2008 Mon, 30 Jun 2008 00:00:00 +0200 Epigenomics AG Successfully Validates Optimized Blood-Based Colorectal Cancer Assay in two Independent Clinical Studies http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-optimiertes-testverfahren-fuer-darmkrebs-bluttest-in-zwei-unabhaengigen-klinischen-stu.html Performance of Septin 9 assay optimized for clinical routine application confirmed as equivalent to...
The first prospective case control study (269 subjects) tested blood samples from 97 patients with, and 172 individuals without, colorectal cancer as confirmed by colonoscopy. The new assay detected 72 of 97 cancer cases (74% sensitivity) and only 14 of 172 individuals without disease (false positive rate of 8% or 92% specificity). The second case control study, composed of an entirely independent set of blood plasma samples from 249 subjects, confirmed the performance observed in the first study. In this study the new, optimized assay identified 63 of 91 colorectal cancer patients of all stages (69% sensitivity) and only 17 of 158 patients without colorectal cancer (89% specificity). In these two independent studies, the performance of the new assay was statistically equivalent to the performance of the research assay previously used in a 2006 study of over 300 subjects, which demonstrated a sensitivity of 72% at a specificity of 90%.

Detailed results of both studies will be presented by Cathy Lofton-Day, PhD, VP Molecular Biology at Epigenomics Inc., at the upcoming Biomarker World Congress 2008 in Philadelphia, PA, USA, May 19 - 21, 2008 and at the upcoming AACR special conference “Cancer Epigenetics” in Boston, MA, USA, May 28 – 31, 2008.

The improved assay marks a significant milestone towards the development and commercialization of Septin 9 DNA methylation biomarker assays, as it provides a reference for the development of Septin 9 based diagnostic products for colorectal cancer. Technical improvements of the assay used in these two studies included a simplified sample handling process and a significant shortening in handling time resulting in a doubling of sample throughput per lab technician. Most importantly, the assay costs could be reduced by 65% and the DNA extraction and the biomarker assay processing are now compatible with widely available laboratory automation solutions. Epigenomics also developed an enhanced and robust algorithm to interpret Septin 9 DNA methylation as a biomarker for colorectal cancer. These improvements position the assay for a potential application to a mass screening approach.

“We considerably simplified our Septin 9 assay, making it significantly cheaper and compatible with laboratory automation solutions. We have repeatedly demonstrated the excellent ability of the Septin 9 biomarker to detect colorectal cancer in blood plasma with high sensitivity and specificity and we found that these data are highly consistent across several independent studies. This clearly demonstrates the robustness of our DNA methylation technology and the Septin 9 biomarker which now has proven its performance in more than 3,500 patient samples,” commented Geert Nygaard, Chief Executive Officer of Epigenomics.

As a next step in Epigenomics’ program for the development of a blood based colorectal cancer screening test, the company aims at demonstrating that Septin 9 performance satisfies the requirements of the most recent U.S. screening guidelines for colorectal cancer and demonstrates a benefit in a validated health economic model. To this end the company plans to initiate PRESEPT, a multi-center and international study to characterize Septin 9 clinical performance and health economic benefits in a U.S. colorectal cancer screening guideline-eligible population. The study is planned to commence in Q2 2008 and will include up to 7,500 average and increased risk individuals, professional society guideline-eligible to receive screening colonoscopy.

About Colorectal Cancer Screening and the Septin 9 Biomarker

Colorectal cancer is the second leading cause of cancer related death. With a 5-year-survival rate of above 90 percent if diagnosed at an early stage, early detection through blood based testing would be valuable. This type of test targets almost 300 million people in Europe, the U.S., and Japan, a market that is worth more than USD 3 billion in total. The gold standard screening test is colonoscopy, an invasive procedure, whereby the physician visually inspects the inside of the colon. This procedure, which has excellent specificity and sensitivity characteristics, not only identifies cancer but also pre-cancerous lesions known as adenomas. Due to the nature of this procedure and its high cost, it is not widely used at short intervals. A non-invasive first-line test therefore would be useful to screen individuals at risk so that they then undergo colonoscopy. Currently, most non-invasive screening is carried out with the Fecal Occult Blood Testing (FOBT) procedure using stool samples. However, due to the inconvenient nature of the test, the compliance rate is comparatively low. The introduction of a more convenient, patient-friendly test could potentially increase the number of individuals tested. If positive, the patients would be followed up by colonoscopy. This could increase the chances of the disease being caught early with the goal of reducing mortality from colorectal cancer.

Epigenomics’ technology aim at sensitively detecting DNA based on specific DNA methylation patterns in blood plasma samples or other body fluids. The Septin 9 gene encodes a protein involved in cell division and is thought to play a role in the onset of cancer. Epigenomics has demonstrated in multiple clinical case control studies with over 3,500 samples from colorectal cancer patients, healthy controls, and patients with non-cancerous colon diseases that methylated DNA of Septin 9 shed by tumors into the blood stream can serve as a biomarker for the sensitive and specific detection of colorectal cancer. As a first strategic partner, Abbott Molecular, Inc. licensed the worldwide non-exclusive IVD rights to Epigenomics’ proprietary Septin 9 biomarker for colorectal cancer. In addition, QuestDiagnostics Inc., the leading provider of diagnostic testing, information and services, obtained the license to commercialize a laboratory-developed test (LDT) for Septin 9 in the U.S.

About DNA Methylation

DNA methylation is a natural and tightly controlled biological process that serves the regulation of genes and the stability of the human genome. Cytosine, one of the four bases in DNA, can be modified by the covalent addition of a methyl group. DNA methylation in gene regulatory regions (i.e. gene promoters) helps control gene activity. Every cell type has its unique DNA methylation “fingerprint” that changes in various normal biological processes and in many diseases, in particular cancer. DNA methylation thus provides a rich source for highly specific biomarkers for organ-specific disease diagnosis, classification and prediction for therapeutic intervention.

About Epigenomics AG

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests can potentially diagnose cancer at an early stage and thereby may reduce mortality from this dreaded disease.

The company develops diagnostic screening tests for the early detection of cancer. Based on body fluid samples (e.g. blood and urine), these tests are aimed at finding cancer at an early stage before symptoms occur. Epigenomics’ product pipeline contains a validated biomarker for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in body fluids. For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry companies. As a first strategic partner, Abbott Molecular Inc. licensed the worldwide non-exclusive IVD rights to Epigenomics’ proprietary Septin 9 biomarker for colorectal cancer. Epigenomics also aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. As a first reference laboratory partner, Quest Diagnostics Inc., the leading provider of diagnostic testing, information and services, obtained the license to commercialize a laboratory-developed test (LDT) for Septin 9 in the U.S.

Partners in the health care industry and the biomedical research community can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 150 patent families through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.

###

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
]]> Epi proColon Company 2008 Mon, 21 Apr 2008 00:00:00 +0200 Epigenomics AG Successfully Optimized Assay Procedure for Cancer Screening Tests http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-testverfahren-fuer-krebs-frueherkennungstests-erfolgreich-optimiert.html Technical study met its objectives Considerable improvements in simplicity, processing time,... Epigenomics AG (Frankfurt, Prime Standard: ECX) has reached a milestone in completing the work on an optimized assay procedure for its blood-based cancer screening tests. The most advanced of these, the colorectal cancer screening test, is now ready for its planned reference laboratory transfer.

After having demonstrated the performance of its biomarker Septin 9 for the convenient and reliable detection of colorectal cancer in blood plasma in December 2006, Epigenomics had focused on the improvement of the assay procedure used to process the patient blood plasma samples and measure the biomarker. In four projects, Epigenomics worked systematically on all major steps of its research workflow to develop an improved assay procedure compatible with routine clinical use and automation. In a technical study, the company tested each improvement separately and their overall combined impact, and demonstrated now that the optimized assay procedure analytically performs equally or better to the previously used research workflow.

Improvements included a simplified sample handling, reduction in the costs of goods by more than 70% and a considerable shortening of the total processing time. In addition the throughput of patient samples that can be processed in parallel by a lab technician was doubled. Most importantly, DNA extraction and the biomarker assay are now compatible with widely available laboratory automation solutions. This allows further increasing of throughput for mass screening applications.

The assay procedure could now be applied to routine clinical use and is now ready for its planned transfer into a reference laboratory to establish a commercial testing service for Epigenomics’ proprietary colorectal cancer early detection biomarker Septin 9. The modified assay procedure also marks a milestone towards the planned development of an in vitro diagnostic (IVD) test kit for automated molecular diagnostics platforms of potential diagnostic industry partners that want to commercialize Epigenomics’ colorectal cancer screening test broadly.

“We took a very systematic approach to optimize all major steps of our assay procedure for blood-based screening tests based on the requirements for reference laboratory use and IVD test kit development. We are very pleased that our study met all its objectives and we have now established a workflow that is simpler, cheaper, and quicker than our previous one and works for high-throughput applications such as our colorectal, prostate and lung cancer screening tests in development,” said Christian Piepenbrock, Chief Operating Officer of Epigenomics.

“Beginning of 2007 we set ourselves the goal of establishing an optimized assay procedure. We reached this goal on time and the positive results of this effort enable us to continue our work on both, our cancer screening test development programs as well as our partnering based commercialization strategy as planned,” commented Geert Nygaard, Chief Executive Officer of Epigenomics.

About Epigenomics AG

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics' defined business strategy covers two complementary core business areas:

The company develops diagnostic screening tests for the early detection of cancer. Based on body fluid samples (e.g. blood and urine), these tests are aimed at finding cancer at an early stage before symptoms occur. Epigenomics’ product pipeline contains a validated biomarker panel for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in body fluids.
Epigenomics aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry players.

As a second core business area, Epigenomics develops specialty diagnostics for individuals at high risk for cancer and cancer patients. These tests include surveillance applications of our colorectal cancer biomarkers and a tissue-based prognostic cancer molecular classification test for prostate cancer patients. Our tissue-based prostate cancer application is developed in strategic partnerships with Qiagen (pre-analytics) and Affymetrix (diagnostic device platform). The biomarkers for cancer specialty diagnostic applications will be made available through testing services in centralized reference laboratories. Epigenomics retains the flexibility to decide on further commercialization as in vitro diagnostic test kits in Europe.

Pharma, diagnostics and biotech partners can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 190 patent families through Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, USA. For more information, please visit Epigenomics’ website at www.epigenomics.com.

###

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

]]> Epi proColon Company 2007 Tue, 03 Jul 2007 00:00:00 +0200 New Clinical Data Further Support Applicability of Epigenomics' Lead Biomarker for Colorectal Cancer Screening http://www.epiprocolon.com/forum/nachrichten/article/neue-klinische-daten-unterstreichen-eignung-von-epigenomics-wichtigstem-biomarker-fuer-die-darmkrebsf.html Prof. Dr. Matthias Ebert Presented Data at Digestive Disease Week 2007 Press Release, Berlin,...
Prof. Ebert pointed out that colorectal cancer mortality could be reduced by detecting precancerous lesions and early stage disease before symptoms occur through convenient organ-specific blood screening tests such as those under development at Epigenomics. Prof. Ebert reviewed a data set demonstrating that the presence of methylated Septin 9 DNA in blood plasma can detect the presence of colorectal cancers of all stages. Additionally, when Septin 9 is combined in a panel with a second DNA methylation biomarker, ALX4, large polyps, pre-cancerous lesions that have a high likelihood of progressing to malignant tumors can also be detected in blood.

For the first time, Prof. Ebert presented original data showing that methylation of the Septin 9 gene is specific to colorectal cancer as it is rarely found in the blood of patients with other cancers or other gastrointestinal diseases.

“Biomarkers that are specific for cancer and the organ in which the cancer occurs are fundamental to effective screening tests,” Prof. Ebert commented. “Such biomarkers allow focusing on the correct organ for definitive diagnosis and help to provide individualized diagnosis for the affected patients more rapidly.”

The Digestive Disease Week is considered the largest and most prestigious meeting in the world for the gastrointestinal professional.

Further Information

The slides of Prof. Ebert’s presentation at the Digestive Disease Week 2007 are available for download from Epigenomics’ website at
http://www.epigenomics.com/en/down_loads/Poster_Scientific_Publications/

About Colorectal Cancer Screening and Epigenomics’ Biomarkers

Colorectal cancer is the second leading cause of cancer related death. With a cure rate over 90% if diagnosed in early stages, early detection through screening tests is vitally important. The market for this type of test could reach about 300 million people worldwide. The gold standard diagnostic test is colonoscopy, an invasive procedure, whereby the physician visually inspects the inside of the colon. This procedure, which has excellent specificity and sensitivity characteristics, not only identifies cancer but also pre-cancerous lesions known as adenomas. Due to the nature of this procedure and its high cost, it is currently not widely used for first line screening in short intervals. A non-invasive first-line screening test therefore should be used to screen larger numbers to identify individuals at risk of having the disease so that they then undergo colonoscopy. Currently, most non-invasive screening is carried out with the fecal occult blood testing (FOBT) procedure using stool samples. However, due to the inconvenient nature of the test, the compliance rate is comparatively low (approximately 16% in the US). The introduction of a more convenient, patient-friendly, competitively performing screening test could potentially increase the number of individuals tested in shorter intervals. If positive, the patients would be followed up by colonoscopy. This could greatly increase the chances of the disease being caught early with the goal of reducing mortality from colorectal cancer.

Epigenomics’ technology is able to detect only a few copies of tumor DNA based on tumor-specific DNA methylation patterns in blood plasma samples or other body fluids. Based on this principle Epigenomics develops convenient tests for the early detection of colorectal and other cancers. The Septin 9 gene encodes a protein involved in cell division and is thought to play a role in the onset of cancer. Epigenomics demonstrated in multiple clinical studies with about 3,000 blood plasma samples of colorectal cancer patients, healthy controls, and patients with non-cancerous colon diseases that methylated DNA of Septin 9 shed by tumors into the blood stream can serve as a biomarker for the sensitive and specific detection of colorectal cancer of all stages and in all locations. The ALX4 gene encodes for a putative transcription factor, suggesting a role in gene regulation. The presence of methylated DNA of both genes, Septin 9 and ALX4, in the bloodstream indicates the presence of larger colon polyps that have a high likelihood of progressing to colon cancer.

Epigenomics is currently optimizing the assay procedure in order to transfer the Septin 9 biomarker assay into a centralized US reference laboratory by the end of the year. A testing service for this biomarker could begin in 2008.

About Epigenomics AG

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics' defined business strategy covers two complementary core business areas:

In cooperation with industry partners, the company develops diagnostic screening tests for the early detection of cancer, mass-market products with huge potentials. Based on easily obtainable body fluid samples (e.g. blood and urine), these tests are aimed at finding cancer at an early stage before symptoms occur. Epigenomics’ product pipeline contains an extensively validated biomarker panel for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in body fluids.
Epigenomics aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry players.

As a second core business area, Epigenomics develops specialty diagnostics for individuals at high risk for cancer and cancer patients. These tests include surveillance applications of our colorectal cancer biomarkers and a tissue-based prognostic cancer molecular classification test for prostate cancer patients. Our tissue-based prostate cancer application is developed in strategic partnerships with Qiagen (pre-analytics) and Affymetrix (diagnostic device platform). The biomarkers for cancer specialty diagnostic applications will be made available through testing services in centralized reference laboratories. Epigenomics retains the flexibility to decide on further commercialization as in vitro diagnostic test kits in Europe and eventually the US.

Pharma, diagnostics and biotech partners can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 200 patent families through Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, USA. For more information, please visit Epigenomics’ website at www.epigenomics.com.

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Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
]]> Epi proColon Company 2007 Mon, 21 May 2007 00:00:00 +0200 Significant Improvement in Colorectal Cancer Early Detection by DNA Methylation Test Through Modified Assay Procedure http://www.epiprocolon.com/forum/nachrichten/article/signifikant-bessere-darmkrebs-frueherkennung-auf-basis-von-dna-methylierungs-tests-durch-veraendertes.html Epigenomics AG presented most recent data at AACR Annual Meeting 2007 Press Release, Berlin,...
“After having shown in 2005 that Septin 9 is an outstanding DNA methylation biomarker for colorectal cancer early detection, we consider this a breakthrough in performance improvement of this biomarker in blood plasma,” commented Christian Piepenbrock, COO of Epigenomics. “This biomarker is methylated in about 90% of all colorectal tumors and understanding the key technical determinants that drive its performance in plasma measurements allows for systematic optimization of the assay procedure for routine use. These assay improvements will benefit not only our Septin 9 test but also the biomarkers in our other cancer screening programs.”

The poster presentation by Cathy Lofton-Day, Ph. D., Vice President Molecular Biology of Epigenomics, focused on the benefits of modifications of the assay procedure and rules for test result interpretation on the performance of Septin 9 for the early detection of colorectal cancer in blood plasma. Using these modifications Septin 9 detected 70% (91 out of 130) of the colorectal cancers in the study and was falsely positive in only 10% (19 out of 183) of the cancer-free controls. When specificity was set at 97% (3% false positive rate in the non-cancerous controls) 63% of cancers were reliably detected. More importantly, the 70% cancer detection rate was also achieved in individuals found to have earlier stage disease (stage I-III, 75 out of 107). Epigenomics is now focusing on further streamlining and simplification of the assay procedure to decrease test costs, improve ease-of-use and thus facilitate transfer into clinical routine use. Further Information The poster presented at the AACR Annual Meeting 2007 is available for download from Epigenomics’ website at http://www.epigenomics.com/en/down_loads/Poster_Scientific_Publications/ About Colorectal Cancer Screening Colorectal cancer is the second leading cause of cancer related death. With a cure rate over 90% if diagnosed in early stages, early detection through screening is vitally important. The market for this type of test could reach about 300 million people worldwide. The gold standard screening test is colonoscopy, an invasive test, whereby the physician visually inspects the inside of the colon. This procedure, which has excellent specificity and sensitivity characteristics, not only identifies cancer but also pre-cancerous lesions known as adenomas. Due to the nature of this procedure and its high cost, it is currently not widely used for first line screening in short intervals. A non-invasive first-line screening test therefore should be used to screen larger numbers to identify individuals at risk of having the disease so that they then undergo colonoscopy. Currently, most non-invasive screening is carried out with the fecal occult blood testing (FOBT) procedure using stool samples. However, due to the inconvenient nature of the test, the compliance rate is comparatively low (approximately 16% in the US). The introduction of a more convenient, patient-friendly, competitively performing screening test could potentially increase the number of individuals tested in shorter intervals. If positive, the patients would be followed up by colonoscopy. This could greatly increase the chances of the disease being caught early with the goal of reducing mortality from colorectal cancer. Epigenomics develops such a blood-based test for the early detection of colorectal cancer by using cancer specific DNA methylation biomarkers for the detection of tumor DNA shed to the blood stream. After having validated Septin 9 as a biomarker with high prevalence in colorectal cancer in several large clinical studies in blood plasma by the end of 2005, much of 2006 was dedicated to finding biomarkers complementary to Septin 9 and, most importantly, further improving the assay procedure for DNA methylation biomarker testing in blood plasma and other body fluids. Epigenomics is currently optimizing the assay procedure in order to be able to transfer the Septin 9 biomarker assay into a US reference lab by the end of the year. A testing service for this biomarker could then start in 2008. About Epigenomics AG Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics' defined business strategy covers two complementary core business areas: In cooperation with industry partners, the company develops diagnostic screening tests for the early detection of cancer, mass-market products with huge potentials. Based on easily obtainable body fluid samples (e.g. blood and urine), these tests are aimed at finding cancer at an early stage before symptoms occur. Epigenomics’ product pipeline contains an extensively validated biomarker panel for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in body fluids. Epigenomics aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry players. As a second core business area, Epigenomics develops specialty diagnostics for individuals at high risk for cancer and cancer patients. These tests include surveillance applications of our colorectal cancer biomarkers and a tissue-based prognostic cancer molecular classification test for prostate cancer patients. Our tissue-based prostate cancer application is developed in strategic partnerships with Qiagen (pre-analytics) and Affymetrix (diagnostic device platform). The biomarkers for cancer specialty diagnostic applications will be made available through testing services in centralized reference laboratories. Epigenomics retains the flexibility to decide on further commercialization as in vitro diagnostic test kits in Europe and eventually the US.. Pharma, diagnostics and biotech partners can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 200 patent families through Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, USA. For more information, please visit Epigenomics’ website at www.epigenomics.com. ### Disclaimer This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.]]> Epi proColon Company 2007 Wed, 18 Apr 2007 00:00:00 +0200 Epigenomics AG: Clinical data show that colon polyps can be detected with simple blood test http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-klinische-daten-zeigen-dass-darmpolypen-mit-einem-einfachen-bluttest-erkannt-werden.html Press release, Berlin, Germany and Seattle, WA, USA
Prof. Ebert together with Epigenomics’s Vice President Molecular Biology, Cathy Lofton-Day, PhD, presented data from a series of studies demonstrating that using Epigenomics’ suite of proprietary DNA methylation technologies on a predefined clinical question delivers high quality biomarkers for detecting cancers organ-specific in blood plasma. The results demonstrate that the sensitive detection of methylated Septin 9 DNA in blood plasma can reliably indicate the presence of colorectal cancers of all stages. Septin 9 combined in a panel with a second DNA methylation biomarker, ALX4, also detects large polyps. These pre-cancerous lesions have a high likelihood of progressing to malignant tumors.

Epigenomics’ DNA methylation technology is able to detect even a few copies of the methylated forms of these genes in blood plasma samples. Based on this principle Epigenomics develops convenient tests for the early detection of colorectal cancer and other cancers.

"Shifting early detection to pre-cancerous colorectal lesions allows the stratification of high risk individuals who will benefit from endoscopic removal of these lesions", commented Prof. Ebert. "Testing for precancerous colorectal lesions thus has the potential to prevent cancers."

The conference, which was attended by some of the world leading experts in epigenetic research, opened with a keynote by Epigenomics’ Scientific Advisory Board member, Peter A. Jones, Director of the USC/Norris Comprehensive Cancer Center. Talks and discussions focused on the increasing utility of epigenetic modifications as diagnostic biomarkers and as targets for novel drugs.

Conference Presentation

The conference presentation by Prof. Ebert and Dr. Lofton-Day is available in the download section of Epigenomics’ webpage.

About the DNA methylation markers/colon cancer

The Septin 9 gene encodes a protein involved in cell division and is thought to play a role in the onset of cancer. Epigenomics demonstrated in multiple clinical studies with about 3,000 blood plasma samples of colorectal cancer patients, healthy controls, and patients with non-cancerous colon diseases that methylated DNA of Septin 9 shed by tumors to the blood stream can serve as a biomarker for the sensitive and specific detection of colorectal cancer of all stages and in all locations. The ALX4 gene encodes for a putative transcription factor, suggesting a role in gene regulation. The data of a smaller feasibility study presented yesterday at the Cambridge Healthtech Institute’s inaugural conference on epigenomicsdemonstrate that the presence of methylated DNA of both genes, Septin 9 and ALX4, in the bloodstream indicates the presence of larger colon polyps, that have a high likelihood of progressing to colon cancer.

About DNA Methylation

Methylation is a natural epigenetic process that occurs when a methyl group binds to one of DNA’s four bases, cytosine. Methylation is responsible for controlling the activity of genes by turning them off when not needed. Measuring the differences in the methylation patterns between healthy and diseased tissue can be used to detect a change in gene activity that could trigger diseases such as cancer. Similarly, DNA methylation patterns can be used to predict a patient’s response to a drug. Epigenomics has developed an industrial process that is able to read and interpret these methylation patterns and uses them as biomarkers for developing molecular diagnostic and pharmacodiagnostic tests.

About Epigenomics AG

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation markers, Epigenomics’ tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics' defined business strategy covers two complementary core business areas:

In cooperation with industry partners, the company develops diagnostic screening tests for the early detection of cancer, mass-market products with huge potentials. Based on easily obtainable body fluid samples (e.g. blood and urine), these tests are aimed at finding cancer at an early stage before symptoms occur. Epigenomics’ product pipeline contains an extensively validated biomarker panel for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate, lung and breast cancer detection in body fluids. Epigenomics has full flexibility to offer these programs as attractive partnering opportunities for global development, marketing and sales in the fast growing cancer molecular diagnostics market.

As a second core business area, Epigenomics develops tissue-based prognostic tests for prostate and breast cancer patients. With a strong focus on prostate cancer applications, these tests are developed in strategic partnerships with Qiagen (pre-analytics) and Affymetrix (diagnostic device platform). In this area Epigenomics also retains the flexibility to decide on potential partnerships for marketing and sales

Pharma, diagnostics and biotech partners can access Epigenomics’ portfolio of proprietary DNA methylation technologies protected by more than 200 patent families through Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, USA. For more information, please visit Epigenomics’ website at www.epigenomics.com.

###

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
]]> Epi proColon Company 2007 Tue, 20 Mar 2007 00:00:00 +0100 Epigenomics AG Presents New Clinical Data on Colorectal Cancer Screening Markers http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-praesentiert-neue-klinische-daten-fuer-darmkrebs-screeningmarker.html Press release, Berlin, Germany and Seattle, WA, USA Epigenomics AG (Frankfurt, Prime Standard: ECX), a molecular diagnostics company developing tests based on DNA methylation, is presenting new clinical data on its colorectal cancer early detection marker in blood. The results indicate that, combined with a second proprietary marker, the test is also able to detect most polyps without many false positive results. Colon polyps are benign proliferations that can give rise to cancer. The risk is considerably high if they are greater than 1 cm in size. Their timely removal is therefore a major contribution to saving patients' lives. Data were presented at the 8th World Congress on Gastrointestinal Cancer in Barcelona from June 28 to July 1.

The study was based on a total of 49 blood plasma samples from patients with colon polyps and 22 patients without polyps. Researchers studied two proprietary Epigenomics markers alone and in combination: Septin9, a marker which has already been presented by Epigenomics earlier this year and ALX4, a previously undisclosed marker identified by Epigenomics.

The combination of the two markers detected clinically relevant polyps with very high sensitivity. Detection rate for polyps larger than 1cm was 67% (12 out of 18 plasma samples from patients with polyps). Sensitivity for large dysplastic polyps (adenomas >1 cm) was 100% and for adenomas with intraepithelial neoplasia, i.e. a substantial likelihood of developing invasive cancer was 80%. The specificity of the combination as tested in asymptomatic patients over 50 years of age was 91%.

"The experiment shows that our development strategy to improve colorectal cancer screening by combining markers into panels clearly works," said Christian Piepenbrock, COO of Epigenomics.

"This study demonstrates that we can find even earlier stages in cancer development," said Catherine Lofton-Day, Ph.D., Vice-President Molecular Biology, Diagnostics. "Therefore, a test based on these markers has the potential to save even more lives."

About DNA methylation
Methylation is a natural epigenetic process that occurs when a methyl group binds to one of DNA’s four bases, cytosine. The presence of methylation is responsible for controlling the activity of genes by turning them off, like a switch, when not needed. By measuring the differences in the methylation patterns between healthy and diseased tissue, a change in gene activity that could trigger diseases such as cancer is detected. Epigenomics has developed an industrial process that is able to read and interpret these methylation patterns.

About the DNA methylation markers
The Septin9 gene is encoding for a protein involved in cell division and is thought to play a role in the onset of cancer. The ALX4 gene encodes for a putative transcription factor, suggesting a role in gene regulation. The DNA methylation technology of Epigenomics is able to detect the methylated forms of these genes in blood samples taken from patients.

About Epigenomics
Epigenomics is a molecular diagnostic company with a focus on the development of novel products for cancer. By detecting and interpreting DNA methylation patterns, Epigenomics’ tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. The company has its headquarters in Berlin, Germany, and a wholly owned subsidiary in Seattle, USA. For more information, please visit our website at www.epigenomics.com.

Poster

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Disclaimer
This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

]]> Epi proColon Company 2006 Wed, 05 Jul 2006 00:00:00 +0200 Epigenomics Presents Data Confirming Screening for Methylated DNA in Blood as Key to Early Colorectal Cancer Detection http://www.epiprocolon.com/forum/nachrichten/article/epigenomics-ag-bestaetigt-nutzen-des-screenings-auf-methylierte-dna-im-blut-fuer-die-frueherkennung-von.html Press release, Berlin, Germany and Seattle, WA, USA Epigenomics AG (Frankfurt, Prime Standard: ECX), a molecular diagnostics company developing tests based on DNA methylation, today confirmed that free-floating DNA gleaned from blood is a key to early detection of colorectal cancer. Epigenomics showed that presence of the methylated form of DNA encoding the so-called Septin 9 gene is found in plasma of up to 57 percent of patients with all stages of colorectal cancer at high levels of specificity (95%). Data from the studies were presented at the 97th AACR Annual Meeting in Washington D.C., USA.

“The presence of methylated Septin 9 DNA in blood is a marker suited as an excellent population screening tool to identify a large number of asymptomatic cancers. Our study is the first of this magnitude and with this level of clinical performance to describe a DNA methylation-based blood test for the early detection of colorectal cancer,” said Catherine Lofton-Day, Ph.D., vice-president, Molecular Biology at Epigenomics. “A blood-based screening assay will be more patient-friendly than the conventional colorectal cancer screening tool, which requires patients to collect and submit fecal samples for fecal occult blood testing – a considerable obstacle to patient compliance.”

The data presented come from two independent studies that determined Septin 9 levels in a total of 1500 patients in three distinct categories. One group was known to be free from colon cancer after examination by colonoscopy. A second group included individuals with non-colorectal cancers and other non-cancerous conditions, and a third group consisted of patients with a confirmed diagnosis of colorectal cancer.

In an initial study of 501 samples, 57% of colorectal cancers were detected. After validating the Septin 9 assay among the three known-status groups in a set of several hundred samples, Lofton-Day and her colleagues predicted the diagnosis of colorectal cancer in an independent set of 790 patients. In this study the detection rate for all colorectal cancers was 50 percent (104 detected in 209 cases). The false positive rate for both studies was between 4 and 6 percent.

“Different stages of colorectal cancers were detected with similar sensitivity, and detection was not affected by location of the tumor in the colon,” Lofton-Day added. “This is a reliable, non-invasive method to detect many patients with colorectal cancer, but who show little or no symptoms.”

While the test to identify methylated Septin 9 DNA in the blood at present is not intended to replace periodic colonoscopy or sigmoidoscopy screening for colon cancer, it can be used more frequently as part of routine yearly physical check-ups to increase the chances of detecting cancer at early stages.

About Epigenomics’ Colon Cancer Screening Test
Epigenomics has successfully validated a panel of DNA methylation markers for incorporation into a colorectal cancer screening test in three large clinical studies involving approximately 2000 patient samples. The first marker from the panel has been exclusively licensed to Roche Diagnostics to be incorporated into a commercially available test. Epigenomics is continuing to identify and validate additional methylation markers for even better sensitivity in detecting colon cancer.

About Epigenomics
Epigenomics is a molecular diagnostic company with a focus on the development of novel products for cancer. By detecting and interpreting DNA methylation patterns, Epigenomics’ tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics collaborates with Roche Diagnostics on the development of several diagnostic products in cancer. The company has its headquarters in Berlin, Germany, and a wholly owned subsidiary in Seattle, USA. For more information, please visit our website at www.epigenomics.com.

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Disclaimer
This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

]]> Epi proColon Company 2006 Mon, 03 Apr 2006 00:00:00 +0200