FDA advisers back DNA-based colon cancer test

By Reuters Staff

(Reuters) - A colon cancer screening method that uses stool samples won the unanimous backing of a U.S. advisory panel on Thursday, paving the way for potential regulatory approval of the DNA test.

A panel of outside experts to the Food and Drug Administration voted 10-0 to recommend approval of the Cologuard screening test made by Exact Sciences Corp.

The FDA usually follows panel recommendations, although it is not required to.

In the company's 10,000-patient, 90-site DeeP-C pivotal trial, Cologuard found 92.3% of colorectal cancer 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.

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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