The FDA has approved Epigenomics' Epi proColon, making it the first and only FDA-approved blood-based colorectal cancer screening test.
Here are four notes:
1. Epi proColon is indicated for colorectal cancer screening in average-risk patients who choose not to undergo CRC screening by recommended methods such as colonoscopy and fecal immunochemical tests.
2. The test only requires a blood sample drawn from the patient as part of routine healthcare provider visits.
3. The sample is then analyzed at a local or regional diagnostic laboratory.
4. Epi proColon will be made available in the United States under a joint commercialization agreement with its strategic partner Polymedco.