Exact Sciences Completes Modular PMA For Cologuard

The molecular diagnostics manufacturer submitted the final module of its PMA for Cologuard and expects to request Medicare coverage later this year through the FDA-CMS parallel review process.

Molecular diagnostics maker Exact Sciences Corp. submitted data from the DeeP-C clinical trial June 7 for its Cologuard stool colorectal screening test, completing the company’s modular PMA application, and paving the way to request Medicare coverage through the FDA-CMS parallel review process.

The DeeP-C trial

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