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EXACT Sciences Says It Submitted Final Module Of PMA For Cologuard To The FDA

EXACT Sciences Corp. (EXAS), a molecular diagnostics company focused on the early detection and prevention of colorectal cancer, Monday said that it submitted the final module of the premarket approval or PMA for Cologuard, the company's stool DNA or sDNA colorectal cancer screening test, to the U.S. Food and Drug Administration or FDA. The final module which was submitted on June 7, comprised of data from the company's DeeP-C clinical trial. The trial analyzed data from about 10,000 patients at 90 sites between the ages of 50 and 84 who were at average risk for colorectal cancer.

EXACT Sciences also announced that the role of COO Maneesh Arora would now also include the oversight of U.S. sales and marketing. The company is also in the search for a senior financial officer.

by RTTNews Staff Writer

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