MADISON, WI – Exact Sciences Corp. (NASDAQ: EXAS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cologuard, the company’s noninvasive, stool DNA colorectal cancer screening test. Cologuard is the first noninvasive screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers and has been proven to find 92 percent of cancers and 69 percent of the most advanced precancerous polyps in average risk patients. Cologuard, which is available through healthcare providers, offers people 50 and older at average risk for colorectal cancer an easy–to–use screening test they can do in the privacy of their own home.
Upon approval, Exact Sciences also received a proposed coverage memorandum from the Centers for Medicare and Medicaid Services (CMS). Cologuard is the first product to take part in the joint FDA and CMS parallel review pilot program in which both agencies simultaneously review medical devices to help reduce the time between FDA approval and Medicare coverage. A final National Coverage Determination is expected to be posted in October/November of this year after a public comment period.