Loading...
Loading...
Exact Sciences Corp.
EXAS today announced that the U.S. Food
and Drug Administration's Molecular and Clinical Genetics Panel of the
Medical Devices Advisory Committee is tentatively scheduled to review
the premarket approval application (PMA) for the company's Cologuard
stool-DNA-based, non-invasive colorectal cancer screening test on March
26, 2014. The date and details of the meeting are subject to
confirmation by the FDA in a Federal Register notice.
Exact submitted the final module of its PMA for Cologuard on June 7,
2013. The application includes data from 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 United States.
See full press release© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in