Sponsor Executive Summary, "Cologuard(™) sDNA-Based Colorectal Cancer Screening Test Exact Sciences Corporation," P130017 (March 27, 2014).
The FDA's Molecular and Clinical Genetics Panel has voted unanimously in support of approving Cologuard as a new DNA stool test for colorectal cancer screening (CRC). Current guidelines for CRC screening recommend conventional colonoscopy; fecal occult blood testing (FOBT) or immunochemical-based fecal occult blood testing (FIT); or sigmoidoscopy combined with high sensitivity FIT/FOBT. Manufacturer Exact Science is seeking FDA approval of Cologuard as an adjunct to colonoscopy for average risk patients over age 50. The new DNA test incorporates both stool DNA and FIT techniques to analyze patients' stool samples for markers associated with the presence of CRC and precancerous lesions. A clinical trial showed the DNA test had greater sensitivity (93.3%) than fecal immunochemical testing (FIT) (73.8%) for cancers deemed clinically relevant. Although the FDA is not bound by the advisory committee's vote, it usually follows the recommendation of its advisory committees.
 Sponsor Executive Summary, "Cologuard(™) sDNA-Based Colorectal Cancer Screening Test Exact Sciences Corporation," P130017 (March 27, 2014).
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