The ^mSEPT9 blood test for colorectal cancer is a product in development by Epigenomics and its partners, and it is among the objectives of the PRESEPT Study to provide scientific evidence that supports the regulatory approval and guideline inclusion of future in vitro diagnostic products that are based on the ^mSEPT9 biomarker. Currently no performance of any SEPT9 based in vitro diagnostic product has been evaluated by the FDA or other regulatory authorities and ^mSEPT9 testing is not recommended by any colorectal cancer screening guideline in the U.S. or elsewhere.

We strongly recommend that individuals that are eligible for colorectal cancer screening follow the guideline recommendations in their respective countries and make best use the screening methods currently available.

Colorectal cancer screening can save your life! Don’t wait!

U.S. Screening recommendations

Beginning at age 50, men and women who are at average risk for developing colorectal cancer should begin screening. Screening can result in the detection and removal of colorectal polyps before they become cancerous, as well as the detection of cancer that is at an early stage. Thus, screening reduces mortality both by decreasing incidence and by detecting a higher proportion of cancers at early, more treatable stages.

The American Cancer Society (ACS) recommends the following screening schedules for the early detection of colorectal cancer in asymptomatic people:

Beginning at age 50, men and women should begin screening with 1 of the examination schedules below:

• A fecal occult blood test (FOBT) or fecal immunochemical test (FIT) every year
• A flexible sigmoidoscopy (FSIG) every 5 years
• Annual FOBT or FIT and flexible sigmoidoscopy every 5 years*
• A double-contrast barium enema every 5 years
• A colonoscopy every 10 years

* Combined testing is preferred over either annual FOBT or FIT, or FSIG every 5 years, alone. People who are at moderate or high risk for colorectal cancer should talk with a doctor about a different testing schedule.

Recommendations by other U.S. agencies or cancer societies may differ from the recommendations by the American Cancer Society. Please consult your family doctor or gastroenterologist for a screening schedule most appropriate for you. For more information on screening guidelines by various cancer societies and agencies check and further information on colorectal cancer here.