Exact Sciences has announced that the US Food and Drug Administration’s (FDA) Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee determined by a unanimous vote of ten to zero that the company has demonstrated safety, effectiveness and a favorable risk benefit profile of Cologuard, the company’s stool-based DNA (sDNA), non-invasive colorectal cancer screening test.
Exact Sciences chairman and CEO Kevin T Conroy noted the company is pleased the Committee strongly supported Cologuard’s approval.
"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," Conroy added.
In the company’s 10,000-patient, 90-site DeeP-C pivotal trial — one of the most extensive colorectal cancer screening studies ever conducted in the US — Exact Sciences’ Cologuard found 92.3% of colorectal cancer in average risk patients based on a combination of DNA and hemoglobin markers.
Exact Sciences submitted the final module of its PMA for Cologuard on 7 June 2013, and the application includes data from that study, which was published online on 19 March 2014, in the New England Journal of Medicine.
The peer-reviewed study, ‘Multi-target Stool DNA Testing for Colorectal-Cancer Screening’ will also appear in the journal’s 3 April 2014 print issue.
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.