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Cologuard gets green light from FDA, CMS

August 12, 2014 1:21 AM UTC

FDA approved Cologuard from Exact Sciences Corp. (NASDAQ:EXAS) 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 review. CMS proposed to cover the test once every three years for beneficiaries aged 50-85 who are asymptomatic and at average risk of developing colorectal cancer. FDA's approval triggers 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.

In March, the Molecular and Clinical Genetics Panel of FDA's Medical Devices Advisory Committee unanimously backed approval of Cologuard. The product is a non-invasive stool DNA test that utilizes a multiplexed quantitative Invader assay for the simultaneous detection of methylated and unmethylated sequences in the promoter region of the vimentin (VIM) gene (see BioCentury Extra, March 27). ...