DNA committee recommends approval of Exact Sciences’ cancer screening test

Special to The Freeman

March 27, 2014

MADISON – Exact Sciences Corp. announced Thursday that a U.S. Food and Drug Administration advisory committee voted to approve the company’s Cologuard, a stool-based DNA, non-invasive colorectal cancer screening test.

The 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, according to the announcement.

“We are pleased the committee strongly supported Cologuard’s approval,” said Kevin T. Conroy, chairman and chief executive of Exact Sciences, in a statement. “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.”

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.

Exact Sciences Corp. is a molecular diagnostics company focused on colorectal cancer based in Madison.