Exact Sciences Corp. (Nasdaq: EXAS) today announced that the U.S. Food and Drug Administration’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the premarket approval application (PMA) for the company’s Cologuard stool-DNA-based, non-invasive colorectal cancer screening test on March 26, 2014. The date and details of the meeting are subject to confirmation by the FDA in a Federal Register notice.
Exact submitted the final module of its PMA for Cologuard on June 7, 2013. The application includes data from the company’s 10,000-patient, 90-site DeeP-C pivotal trial, one of the most extensive colorectal cancer screening studies ever conducted in the United States.
“We look forward to discussing with the panel members the DeeP-C clinical trial results and the value of colorectal cancer screening with Cologuard,” said Kevin T. Conroy, Exact’s president and CEO. “The scheduling of this advisory panel meeting marks another milestone in bringing Cologuard to market.”