Study Data

The performance of the mSEPT9 biomarker has been evaluated in several case control studies with almost 4.000 individuals and with 1.500 out of 8.000 included individuals identified in a prospective study 1-3.

During these studies the mSEPT9 biomarker correlated reliably with the disease, with an overall sensitivity for colorectal cancer of ~70 % at a specificity of  ~90 %.

Study overview

2003-2005

Discovery of the mSEPT9 biomarker, development of the workflow

2007

Execution of five case control studies with simplified workflow 1,2,3

2008

Execution of two case control studies, Sensitivity/Specificity 70/90 %

2008

Initiation of Prospective Study (PRESEPT)  PRESEPT  was conducted at 32 centers with more than 7.900 individuals in the USA and Germany

2009

Execution of a CE Study and approval of CE-marked Septin9 test4

Since 2009

 Execution of three independent case control studies6,7,8

March 2010

Completion of prospective PRESEPT Study5 (7941 patients enrolled)

Since Nov. 2010

Execution of the observational study in Germany with approximately 300 general practitioners

↓ References
  1. Lofton-Day et al, DNA-Methylation Biomarkers for Blood-Based Colorectal Cancer Screening, Clin. Chem, 2008; 54: 414-23
  2. Grützmann et al, Sensitive detection of colorectal cancer in peripheral blood by septin 9 DNA methylation assay, PLOS One, 2008; 3(11): e3759
  3. DeVos T. et al, Circulation methylated SEPT9 DNA in Plasma as a Biomarker for Colorectal Cancer, Clin. Chem, 2009; 55: 7m 1337-1346
  4. Weiss G. and T. Rösch, Potenital of a new blood Test for Colorectal Cancer Screening-the Septin9 Gene Biomarker, European Oncology, Volume 6, Issue 1, (2010)
  5. Church et al, Prospective clinical validation of an assay for methylated Septin 9 DNA in human plasma as a colorectal cancer screening tool in average risk men and women 50 years and older, Oral Presentation at DDW, Chicago, IL, 2010
  6. mSEPT9 real-time PCR Assay, Gebrauchsanleitung, Abbott Molecular, 2009
  7. Rösch et al, Prospective Clinical Validation of a Biomarker, Methylated SEPT 9 DNA, for Colorectal Cancer Detection in Plasma of Average Risk Men and Women Over the Age of 50, Poster Presentation at UEGW, Barcelona, Spain, 2010
  8. Heichmann et al, Use of Septin 9 Methylated DNA Biomarker to Detect Cancer in the Blood of Colorectal Cancer Patients Poster Presentation at ASCO-NCI-EORTC Annual Meeting on Molecular Markers, Hollywood, FL, 2010


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