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# FDA OKs Epigenomics PMA for Colon Cancer Test
- URL: https://www.fdaweb.com/fda-oks-epigenomics-pma-for-colon-cancer-test/
- Published: 2016-04-13T12:00:00.000Z
- Updated: 2026-09-14T20:54:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135358

> FDA has approved an Epigenomics PMA for its Epi proColon, the first FDA-approved blood-based colorectal cancer screening test. The device is indicated for colorectal cancer screening in average-risk patients who choose not to undergo colorectal cancer screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests. Approval was based on safety and efficacy data from three major clinical studies. “The test has also demonstrated its potential to significantly increase participation rates in colorectal cancer screening,” Epigenomics says.  
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> The test requires a simple blood sample to be drawn as part of routine healthcare provider visits, according to the company. “There are no dietary restrictions or alterations in medication required for the test,” it says. The sample will be analyzed at a local or regional diagnostic laboratory.  
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> FDA’s approval also requires Epigenomics to initiate a post-approval study to show the long-term benefit of blood-based colorectal cancer screening using the test.