Exact Sciences Launches First Stool-Based DNA Screening Test For Colorectal Cancer
With the cost of treating colon cancer in the US projected to reach $20 billion annually by 2020, Exact Sciences hopes to improve colorectal cancer screening and survival rates with Cologuard, the first FDA-cleared noninvasive screening test that analyzes both DNA and blood biomarkers in stool.
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Epigenomics has finally gained US FDA approval for its Epi proColon noninvasive colorectal cancer screening test, ending what has been a long, obstacle-filled journey for the German-US molecular diagnostics company.
CMS granted the company a broad-based national coverage policy at breakneck speed and a positive preliminary payment decision to boot for the Cologuard DNA stool test. It is the first national coverage determination resulting from the FDA-CMS parallel review pilot.
CMS opened a national coverage determination for Exact Sciences Cologuard, the first stool-based colorectal cancer screening test on the same day FDA approved the test. This is the first simultaneous approval/coverage determination under FDA and CMS’ joint parallel review program.