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FDA 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.