MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS) today announced that the Centers for Medicare & Medicaid Services (CMS) issued its final National Coverage Determination (NCD) for Cologuard, making it the first and only Food and Drug Administration (FDA) approved stool DNA test for the detection of colorectal cancer and precancer covered by Medicare. Coverage will go into effect immediately. Exact Sciences is still awaiting a preliminary pricing determination from CMS.
The 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.
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