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FDA Panel Schedules Date to Review Exact Sciences' Cologuard Application

NEW YORK (GenomeWeb News) – Exact Sciences said after the close of the market Tuesday that the US Food and Drug Administration's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the firm's premarket approval application for its Cologuard DNA-based, non-invasive colorectal cancer screening test on March 26, 2014.

The date is subject to confirmation by the FDA in the Federal Register.

In June Exact Sciences submitted the third and final module of the PMA for Cologuard. That module contained data from Exact Sciences' Deep-C clinical trial, which analyzed data from about 10,000 patients at 90 sites between 50 and 84 years of age who were at average risk for colorectal cancer.

Exact Sciences management recently said that the firm is participating in the joint FDA-Medicare parallel review program, and the company expects to make a national coverage decision submission to the Centers for Medicare and Medicaid Services during the first quarter of 2014 "shortly before an FDA advisory committee meeting." A preliminary Medicare decision on Cologuard is expected around the same time as FDA approval, and about 90 days later, a final decision by Medicare is anticipated along with a final reimbursement rate.

In Wednesday morning trade on the Nasdaq shares of Exact Sciences were down around 1 percent at $12.14.