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Ovarian Cancer Screening Test Not Approved: FDA

Law360 (October 8, 2008, 12:00 AM EDT) -- Officials from the U.S. Food and Drug Administration have accused Laboratory Corporation of America Holdings, one of the world's largest clinical laboratories, of selling an ovarian cancer screening test without regulatory approval.

According to the FDA, LabCorp has been violating the Food, Drug and Cosmetic Act since June when it began selling OvaSure, an early stage ovarian cancer screening test. The test must be approved by the FDA before it can be marketed or sold because it is intended for use in the diagnosis of disease,...
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