The Centers for Medicare & Medicaid Services (CMS) recently issued a positive national coverage determination (NCD) for Cologuard, by Exact Sciences, Madison, Wis, making it the only FDA-approved stool DNA test for the detection of colorectal cancer and precancer to be covered by Medicare. Coverage will go into effect immediately. Exact Sciences is still awaiting a preliminary pricing determination from CMS.


Kevin T. Conroy, Exact Sciences

CMS granted the NCD after conducting a comprehensive review 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.

“We are pleased with CMS’s final coverage determination for Cologuard and would like to thank both CMS and FDA for giving Exact Sciences the opportunity to participate in the parallel review pilot program,” says Kevin T. Conroy, president, chairman, and CEO of Exact Sciences. “Colorectal cancer is often considered the most preventable yet least prevented cancer, due to the lack of patient compliance with screening. CMS’s decision to cover Cologuard will provide Medicare’s 50 million patients with access to this accurate screening option.”

With early detection through screening, colorectal cancer is considered highly treatable. However, it is estimated that 23 million Americans between 50 and 75 do not undergo screening as recommended, and as a result, colorectal cancer remains the second-leading cancer killer in the United States. For those whose cancer is detected at an earlier stage, the 5-year survival rate can be greater than 90%.

Cologuard offers people 50 years and older who are at average risk for colorectal cancer an easy-to-use screening test that they can perform in the privacy of their own home. Cologuard has been proven to find 92% of colorectal cancers in average-risk patients, with 87% 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 for Cologuard can be found via the CMS website.

Stool DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the US Multi-Society Task Force on Colorectal Cancer. Exact Sciences has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. For more information, visit Exact Sciences.