Resources for Food and Drug Administration (FDA)

FDA: LabCorp’s marketing of ovarian-cancer test violates law

www.bizjournals.com

The federal Food and Drug Administration has told Burlington-based Laboratory Corporation of America Holdings that it is violating the law by selling a test for ovarian cancer without regulatory approval. In a letter dated Sept. 29, Steven I. Gutman, director in the office of In Vitro Diagnostic Device Evaluation and Safety with the FDA, wrote to LabCorp president and CEO David P. King that the company’s OvaSure has not received proper approval. “Because you do not have marketing clearance or approval from the FDA, marketing OvaSure is in violation of the law,” the letter states.

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