FDA approves first blood test for colorectal cancer

The FDA has approved the Epi proColon blood-based screening test for the early detection of colorectal cancer, the manufacturer announced.

The Epi proColon (Epigenomics) “is a blood test that detects methylated Septin9 DNA, a differential blood biomarker found to be specifically hypermethylated in colorectal cancer, and not normal colon tissue,” according to materials from an FDA medical device advisory committee. “Hypermethylated Septin9 tumor DNA shed into the bloodstream displays a unique and discriminating methylation pattern that is detectable in plasma by real-time PCR.”

The test is indicated for colorectal cancer screening in average-risk patients who opt not to be screened by colonoscopy or stool-based fecal immunochemical tests, as recommended by current guidelines, according to a press release. It requires a blood sample to be analyzed at a local or regional diagnostic laboratory, and does not require dietary restrictions or changes in medications.

The approval follows safety and efficacy data from three clinical studies, and the demonstrated potential of increasing colorectal cancer screening rates.

The test will be made available in the U.S. under a joint commercialization agreement between Epigenomics and Polymedco, and Epigenomics will begin a post-approval study of the test’s long-term benefits, according to the press release.

An FDA panel previously recommended that the benefits of Epi proColon outweigh the risks.

Reference:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/UCM390238.pdf