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New Blood Test for Colon Cancer Early Detection Gets FDA Panel Nod

New Blood Test for Colon Cancer Early Detection Gets FDA Panel Nod
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CMS finalizes blood-based colon cancer screening coverage

CMS finalizes blood-based colon cancer screening coverage
Modern Healthcare
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CMS has finalized a memo describing criteria for the coverage of blood-based colorectal cancer screening tests. The agency did deny coverage for Epigenomics Epi ProColon assay, citing issues with sensitivity.
The decision could impact companies developing genomic and epigenomic blood tests for colorectal cancer including Guardant Health, Freenome, and Exact Sciences.
The draft national coverage decision memo, which was issued last October, has retained its main conclusions largely unchanged apart from the removal of a requirement for covered tests to be included in professional society guidelines or recommended by the U.S. Preventive Services Task Force. ....

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