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Exact Sciences Completes PMA Submission to FDA for Cologuard

NEW YORK (GenomeWeb News) – Exact Sciences has submitted the third and final module of its premarket approval application to the US Food and Drug Administration for its Cologuard colorectal cancer screening test, the company said today.

The module was submitted on June 7 and completes Exact Sciences' PMA submission process for the test. The first module was submitted in December, followed by the second module's submission in February.

The third module contains data from Exact Sciences' Deep-C clinical trial, which analyzed data from about 10,000 patients at 90 sites between 50 and 84 years of age who were at average risk for colorectal cancer.

"The completion of our PMA submission to the FDA is the most significant milestone in the company's history and a big step forward in helping physicians make the battle against colorectal cancer a winning one," Exact Sciences President and CEO Kevin Conroy said in a statement. "Now we look forward to continuing to work with the FDA through the review process."

The Madison, Wis.-based company said that it plans to submit the Deep-C study's pivotal data set for publication in a peer-reviewed journal, present the data at a major medical meeting, or both.

It further said that it is expanding the responsibilities of COO Maneesh Arora to include oversight of US sales and marketing. The firm is currently building out its commercial leadership team and searching for a senior financial officer.

In Monday morning trading on the Nasdaq, shares of Exact Sciences inched up 1 percent at $13.07.