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Exact Sciences completes Cologuard PMA submission

June 11, 2013 1:36 AM UTC

Exact Sciences Corp. (NASDAQ:EXAS) said on Monday it submitted the final module of a PMA to FDA for Cologuard as a colorectal cancer screening test. Cologuard is under parallel review by FDA and Centers for Medicare & Medicaid Services; Exact Sciences said it is the first device to undergo such parallel review. In 2011, the agencies launched the voluntary program, which could reduce the time between FDA approvals and CMS National Coverage Determinations (NCDs) (see BioCentury Extra, Oct. 7, 2011). ...