Laboratory Corporation of America Holdings Ovarian Cancer Test Sales Are Illegal, FDA Warns

The Business Journal of the Greater Triad Area -- 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.

The FDA letter said that if LabCorp did not “take prompt action to correct these violations,” possible regulatory actions against the company could include seizure, injunction or monetary fines. The letter also states that other federal agencies receive copies of warning letters so they may consider that information when awarding government contracts.

Eric Lindblom, a spokesman for LabCorp, said the company is in discussions with the FDA to determine its next steps.

“LabCorp is committed to working in partnership with the FDA to address these regulatory issues,” he said. “While we are disappointed in the letter ... we share the FDA’s interest in avoiding unnecessary regulatory burdens in diagnostic testing and in ensuring safety for patients.”