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Exact Sciences' Colon Cancer Test Gains Approval from FDA Advisers Despite Associated Risks
A panel of Food and Drug Administration advisers has voted to endorse an experimental stool test that uses DNA to detect colon cancer and precancerous growths.
The FDA's committee of genetic experts voted 10-0 that the benefits of Exact Sciences' Cologuard test outweigh its risks. The vote amounts to a recommendation for the FDA to approve the test from Exact Sciences of Madison, Wis. The agency is not required to follow the panel's advice, but often does.
"We are pleased the committee strongly supported Cologuard's approval," Kevin T. Conroy, chairman and chief executive of Exact Sciences, said in a statement. "We look forward to continuing our work with the FDA to complete its review of Cologuard and remain committed to addressing the growing unmet needs in colorectal cancer screening."
Doctors have long used stool tests to look for hidden blood, a sign of possible tumors and precancerous polyps.
Cologuard and other DNA tests in development detect minute genetic changes associated with cancer cells in the colon.
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Source: abc News
