U.S. advisers back DNA-based colon cancer test

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U.S. advisers back DNA-based colon cancer test

(Reuters) - A colon cancer screening method that analyzes DNA from stool samples won the unanimous backing of a U.S. advisory panel on Thursday, paving the way for potential regulatory approval of the non-invasive test. A panel of outside experts advising the Food and Drug Administration voted 10-0 to recommend approval of the Cologuard screening test made by Exact Sciences Corp. The company said a large clinical trial found that its test detected 92.3 percent of colorectal cancers in average-risk patients based on a combination of DNA and hemoglobin markers. While a colonoscopy is considered the most accurate method of detecting colon cancer and polyps, many people avoid the test, which involves inserting a flexible tube into the colon. If Cologuard is approved by the FDA, patients who have a positive cancer finding with the test, which identifies abnormal cells shed in the stool, would then undergo a colonoscopy.

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