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U.S. advisers back DNA-based colon cancer test
March 27, 2014 / 7:51 PM / 4 years ago

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

March 27 (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.

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.

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

Shares of Exact Sciences were halted on the Nasdaq on Thursday pending outcome of the FDA panel meeting. The shares closed at $13.75 on Wednesday, and had gained about 40 percent over the past 12 months.

Reporting By Deena Beasley; Editing by Alden Bentley

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