Stool DNA colorectal cancer screening assay regulatory update

FDA approved a PMA from Exact Sciences for Cologuard as a non-invasive DNA screening test for colorectal cancer. Separately, CMS issued a proposed National Coverage Determination (NCD) for Cologuard - the first product reviewed through a pilot parallel FDA/CMS assessment. CMS proposed to cover the test once every 3 years for beneficiaries ages 50-85 years who are asymptomatic and at average risk of developing colorectal cancer. The proposed NCD is subject to a 30-day comment period; final action is expected in October or November.

FDA’s approval triggered a $500,000 milestone payment to the Mayo Foundation for Medical Education and Research (Rochester, Minn.) under a 2009 deal granting Exact Sciences rights to Mayo patents covering stool- or blood-based cancer diagnostics. Exact Sciences has rights from MDxHealth S.A. (Euronext:MDXH, Liege, Belgium) to an epigenetic biomarker used in Cologuard under a July 2010 deal (see BioCentury, Aug. 2, 2010). Exact Sciences said Cologuard is already available in the U.S. for $599. ...