publication date: Mar. 28, 2014


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By Matthew Bin Han Ong



The FDA Molecular and Clinical Genetics Panel voted 10-0 to recommend approval of Cologuard—a noninvasive, multitarget stool DNA screening test for colorectal cancer.

Sponsored by Exact Sciences Corp., Cologuard outperformed a standard fecal immunochemical test in a study published March 19 in the New England Journal of Medicine.

The advisory panel, part of the Medical Devices Advisory Committee, recommended March 27 that Cologuard be approved for use in conjunction with colonoscopy and other test methods, in accordance with recognized screening guidelines.

Cologuard was tested against FIT in a cross-sectional study at 90 sites in the U.S. and Canada in persons at average risk for colorectal cancer. The study, DeeP-C, enrolled 12,776 participants, and 9,989 had results that could be fully evaluated.

Cologuard detected 92.3 percent of the 65 participants diagnosed with colorectal cancer on colonoscopy. FIT detected 73.8 percent (p=0.002) of the colorectal cancers.

The panel’s unanimous vote—which is almost certain to lead to approval—is important for the gastroenterology community, because Cologuard’s high sensitivity and noninvasive sample collection could make it a viable alternative to colonoscopy, even if it’s not labeled as a replacement for colonoscopy.

The price for Cologuard has not been set, but Exact Sciences has indicated that it’s likely to cost about $500 per test. The price of a regular colonoscopy can be as low as below $1,000 or as high as $5,000, depending on where the procedure is performed. The choice of anesthesia affects the price, as does … Continue reading 40-13 Stool DNA Colorectal Cancer Screening Test 1

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