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March 19, 2014
08:06 EDTEXASExact Sciences announces DeeP-C study results published
Exact Sciences announced that results from its DeeP-C clinical study have been published online 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 April 3 print issue. The company said, "In our clinical study, the data show that Cologuard, the multi-target stool-based DNA test, is highly sensitive in detecting colorectal cancer and higher risk pre-cancerous polyps in a large, diverse average-risk patient population and has the potential to be an important screening tool.” The Exact Sciences Cologuard screening test is an investigational device currently under review by the U.S. Food and Drug Administration and is not available for sale in the U.S. The FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to review Exact Science’s PMA application for Cologuard 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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