advisers back DNA-based colon cancer test
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[March 28, 2014]
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.
The FDA usually follows panel recommendations, although it is not
The American Cancer Society estimates about 50,000 deaths from
colorectal cancer in the United States this year. It is the third-leading cause of cancer-related deaths in the United States when men
and women are considered separately, and the second-leading cause
when both sexes are combined.
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Shares of Exact Sciences, which were halted on the Nasdaq on
Thursday, were up 75 cents, or 5.5 percent at $14.50 in after-hours
trading. The shares have gained more than 40 percent over the past
(Reporting by Deena Beasley; editing by Alden Bentley and Jonathan Oatis)
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