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

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.

A modular PMA submission is broken into several clearly defined parts submitted over time. Together, the modules constitute a complete PMA submission.

The Madison, Wis.-based firm recently said that it planned on submitting the first module of the PMA application in December. The second module, the analytical module, will follow in February 2013, and in March top-line results from its DeeP-C pivotal trial for the test are expected. A clinical module will then be submitted to FDA.

Exact Sciences announced in mid-November the completion of patient enrollment for the trial.

"The submission of the first, manufacturing module of our PMA application is an important milestone for the company," Kevin Conroy, president and CEO of Exact Sciences, said in a statement on Monday. "With work on the first module finished, we are focused on completing and submitting the analytical and clinical modules."

In Tuesday morning trade on the Nasdaq, shares of Exact Sciences were up 2 percent at $10.14.