Exact Sciences Submits First Module of PMA for Cologuard MDx Colorectal Cancer Screen to FDA | GenomeWeb

NEW YORK (GenomeWeb News) – Exact Sciences said after the close of the market on Monday that it submitted the first module of its premarket approval submission to the US Food and Drug Administration for its Cologuard molecular diagnostic test.

The module is comprised of the required documentation detailing the manufacturing and quality control systems for Cologuard, a colorectal cancer screening test. The module was submitted on Dec. 7 and FDA has 45 days to accept the submission.

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