committee recommends approval of Exact Sciences’ cancer
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
“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.