CMS to cover Exact Sciences' noninvasive stool DNA screening test for colorectal cancer

Oct. 10, 2014
The FDA-approved Cologuard noninvasive stool DNA screening test for colorectal cancer and precancer from Exact Sciences (NASDAQ: EXAS), a molecular diagnostics company, will be covered by Medicare.

The FDA-approved Cologuard noninvasive stool DNA screening test for colorectal cancer and precancer from Exact Sciences (NASDAQ: EXAS; Madison, WI), a molecular diagnostics company, will be covered by Medicare. The company is still awaiting a preliminary pricing determination from the Centers for Medicare & Medicaid Services (CMS; Baltimore, MD).

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The National Coverage Determination (NCD) was based on the comprehensive review by the federal government agency as part of the FDA and CMS parallel review pilot program. Cologuard is the first medical device to receive FDA approval and a final NCD as part of the parallel review process.

Colorectal cancer is highly treatable with early detection through screening. However, 23 million Americans between 50 and 75 are not getting screened as recommended and, as a result, colorectal cancer remains the second-leading cancer killer in the U.S. For those whose cancer is detected at an earlier stage, the five-year survival rate can be greater than 90 percent.

Cologuard offers people 50 years and older who are at average risk for colorectal cancer an easy-to-use screening test that they can do in the privacy of their own home. Cologuard has been proven to find 92 percent of colorectal cancers in average risk patients with 87-percent specificity. Cologuard does not require medication, dietary restrictions, or bowel preparation prior to taking the test. It is the first noninvasive screening test for colorectal cancer that analyzes both stool-based DNA and blood biomarkers to detect cancer and precancer.

The final NCD can be found online at www.cms.gov.

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