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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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January 28, 2015
15:32 EDTEXASExact Sciences announces Norton Healthcare to adopt Cologuard
Exact Sciences announced Norton Healthcare is the first healthcare system in Kentucky to offer Cologuard, the first and only FDA-approved noninvasive stool DNA screening test for colorectal cancer. Cologuard makes it easy for average risk patients 50 years and older to get screened at their convenience and in the privacy and comfort of their own home without having to worry about taking time off work to prepare for an invasive procedure. “Norton Healthcare is proud to be the first healthcare provider in Kentucky to offer this important new advancement that can help increase screening compliance for colon cancer,” said Dr. Thomas Woodcock, an Oncology Specialist with the Norton Healthcare Cancer Institute. “The decision to offer this at-home screening tool reflects the commitment of the Norton Cancer Institute to lead the way in innovative cancer care and prevention.”

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