The Food and Drug Administration has issued a warning to Burlington-based Laboratory Corporation of America Holdings that it is violating the law by illegally marketing a blood test OvaSure to detect ovarian cancer.  Introduced in June, the test was looked upon with great hope as it claimed to detect ovarian cancer at an early, treatable stage; a claim some experts including the Society of Gynecologic Oncologists say is incorrect.

Steven I. Gutman, director in the office of In Vitro Diagnostic Device Evaluation and Safety with the FDA, wrote to David P. King, CEO and LabCorp president to say that the company had not received proper approval to market OvaSure. “Because you do not have marketing clearance or approval from the FDA, marketing OvaSure is in violation of the law,” states the letter. It further added that if LabCorp did not “take prompt action to correct these violations,” seizure, injunction or monetary fines could be possible regulatory actions taken against the company.

Eric Lindblom, a spokesman for LabCorp, said the company was in discussions with the F.D.A. “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.”

Tests that are developed and performed in a single laboratory are exempt from regulations but the FDA said OvaSure did not come under this exemption as the test was developed by Yale University and materials for the test were not manufactured by LabCorp. The F.D.A added that this did not represent a new policy and similar action had been taken last year against LabCorp in a colon cancer screening test.

Dr. Gil Mor, the lead developer of OvaSure at Yale and LabCorp, the nation’s second largest clinical laboratory company, has said that in studies that were conducted the test was accurate.