FDA panel unanimously backs Cologuard

The Molecular and Clinical Genetics Panel of FDA's Medical Devices Advisory Committee voted 10-0 that the benefits of Cologuard from Exact Sciences Corp. (NASDAQ:EXAS) outweigh the product's risks as an adjunctive screening test in patients who are at average risk for colorectal cancer. The panel also unanimously voted that there is reasonable assurance that Cologuard, a non-invasive stool DNA test, is safe and effective.

Cologuard is under a pilot parallel FDA/CMS review. Exact Sciences said it does not have a timeframe on when to expect a decision from CMS on a National Coverage Determination (NCD). Trading of Exact Sciences was halted on Thursday. ...