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News Breaks
February 5, 2014
09:01 EDTEXASFDA confirms date for Exact Sciences' advisory committee
Exact Sciences announced that the U.S. Food and Drug Administration has confirmed by notice in the Federal Register that its Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will review the premarket approval application for the company’s Cologuard stool-DNA-based, non-invasive colorectal cancer screening test on March 27.
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November 25, 2014
12:45 EDTEXASExact Sciences says CMS issues final payment decision regarding Cologuard
Exact Sciences announced that the Centers for Medicare & Medicaid Services,CMS, has issued its final payment decision regarding Cologuard and will reimburse it at $502 per test. Cologuard is the first and only FDA-approved noninvasive stool DNA colorectal cancer screening test. The final payment decision follows a comprehensive evaluation by the agency as part of a joint FDA and CMS parallel review pilot program. Cologuard is the first technology to gain approval through this program. “CMS’ final payment decision represents a major milestone by providing 50M Medicare patients access to this noninvasive colorectal cancer screening option,” said Kevin Conroy, president, CEO and chairman of Exact Sciences. “We thank FDA and CMS for giving Exact Sciences the opportunity to bring this new screening option to patients and physicians.”
November 20, 2014
07:24 EDTEXASGoldman to hold a conference
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