FDA approves 1st CRC screening blood test: 4 notes

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.

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