Exact Sciences (Madison, WI) has achieved a milestone with its fluorescence-based molecular diagnostics tool for noninvasive colorectal cancer and precancer testing: Cologuard will be covered by Medicare. The company is now awaiting a preliminary pricing determination from the Centers for Medicare & Medicaid Services (CMS).
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.
Cologuard, an easy-to-use test that patients can do at home, analyzes both stool DNA and blood biomarkers. Colorectal cancer is highly treatable with early detection through screening, but many people are not screened, and colorectal cancer remains the second-leading cancer killer in the U.S.