MADISON, WI. – Exact Sciences Corp. (NASDAQ: EXAS) today announced that the U.S. Food and Drug Administration's (FDA) Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee determined by a unanimous vote of 10 to zero that Exact Sciences has demonstrated safety, effectiveness and a favorable risk benefit profile of Cologuard ®, the company's stool-based DNA (sDNA), non-invasive colorectal cancer screening test.
"We are pleased the Committee strongly supported Cologuard's approval," said Kevin T. Conroy, chairman and chief executive of Exact Sciences. "We look forward to continuing our work with the FDA to complete its review of Cologuard and remain committed to addressing the growing unmet needs in colorectal cancer screening. We thank the FDA and its advisory committee for its careful consideration of Cologuard. We also appreciate the opportunity to participate in the innovative FDA/CMS parallel review program. "
In 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—Exact Sciences' Cologuard found 92.3% of colorectal cancer in average risk patients based on a combination of DNA and hemoglobin markers. Exact Sciences submitted the final module of its PMA for Cologuard on June 7, 2013, and the application includes data from that study, which was published online on March 19, 2014, in the New England Journal of Medicine. The peer-reviewed study, "Multi-target Stool DNA Testing for Colorectal-Cancer Screening" will also appear in the journal's April 3, 2014 print issue.
The FDA is not bound by the recommendation of its advisory committee, but will consider the committee's guidance as it evaluates the Cologuard PMA.