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About Epi proColon® 2.0 CE

The Epi proColon® 2.0 CE is a qualitative assay for the real-time PCR detection of methylated Septin 9 DNA in bisulfite converted DNA from human plasma samples. Presence of methylated Septin 9 is associated with, and may aid in, the detection of colorectal cancer.

Please note:

      • The Epi proColon® test is not intended for patients defined as having elevated risk for developing CRC based on previous history of colorectal polyps, CRC or related cancers, inflammatory bowel disease (IBD), chronic ulcerative colitis (CUC), Crohn’s disease, familial adenomatous polyposis (FAP). Persons at higher risk also include those with a family history of CRC, particularly with two or more first degree relatives with CRC, or one or more first degree relative(s) less than 50 years of age with CRC.
      • The Epi proColon® test has not been evaluated in patients who have been diagnosed with a relevant familial (hereditary) cancer syndrome, such as non‐polyposis colorectal cancer (HNPCC or Lynch Syndrome), Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner’s syndrome, Turcot’s (or Crail’s) syndrome, Cowden’s syndrome, Juvenile Polyposis, Cronkhite-Canada syndrome, Neurofibromatosis, or Familial Hyperplastic Polyposis, or in patients with anorectal bleeding, hematochezia, or with known iron deficiency anemia.

 

Important Considerations

      • Patients without a diagnosed CRC but with documented chronic conditions, comorbidity or on medications were tested to determine potential effects on
        Epi proColon 2.0 CE results. No significant impacts were detected.
      • Positive test results have been observed in healthy subjects and in patients diagnosed with chronic gastritis (2 in 17 patients), esophagitis (1 in 8 patients) and non-rheumatoid arthritis (1 in 10 patients), and lung (5 in 15 patients), breast (3 in 23 patients) and prostate (4 in 40 patients) cancers.
      • Positive test results have been found in pregnant women.
      • Test results should be interpreted by a healthcare professional.

For more information, please refer the Epi proColon® 2.0 CE Instructions for Use (IFU 0009), available here for download.