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March 24, 2014
09:21 EDTEXASFDA says Exact Sciences colorectal cancer screening tool study met objectives
Exact Sciences' Deep-C study met the primary objectives with respect to both required sensitivity and specificity of the company's Cologuard test compared to colonoscopy, FDA staff wrote in briefing documents ahead of the March 27 meeting of the Molecular and Clinical Advisory Committee Panel. With respect to the secondary objectives, Cologuard sensitivity is higher than FIT for both CRC and AA, FDA staff noted. Cologuard is an in vitro diagnostic device designed to analyze patients’ stool for the presence of colorectal cancer. Reference Link
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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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