LabCorp, the U.S.'s second largest testing provider is no longer offering its OvaSure cancer test, consequent to a warning letters from the FDA in September, which questioned the clinical validity of the test.

"LabCorp does not agree with the assertion in the Warning Letter that OvaSure is a medical device subject to regulation under the Federal Food, Drug, and Cosmetic Act ("FDC Act")," states the letter to the FDA from F. Samuel Eberts, LabCorp's senior vice president and general counsel, dated October 20. "As we have previously stated, we believe that laboratory developed assays are not medical devices within the meaning of the FDC Act and that they are not subject to regulation as medical devices."

The September warning letter was the second sent to LabCorp regarding the OvaSure test, which is intended to identify high risk women who might have ovarian carcinoma. In both letters, FDA's director of the Office of In Vitro Diagnostic Device Evaluation and Safety, Steven Gutman, had expressed concern that the test was high risk and had not been adequately validated. In the most recent letter, Gutman stated, Based on the information collected, FDA has determined that the OvaSure™ is a test that was designed, developed, and validated by investigators at Yale University and not LabCorp. Instructions for use and performance characteristics appear to have been developed by Yale investigators. In addition, the materials being used to produce this test ...[are] based on specifications by the workers at Yale. This device is not within the scope of laboratory developed tests over which the agency has traditionally exercised enforcement discretion." The letter went on to state that the FDA's review indicated the product is a device under section 201(h) of the Food, Drug, and Cosmetic Act (FDCA or Act), 21 U.S.C. 321(h), and marketing approval or clearance for the product was needed.
LabCorp's Eberts responded in letter that the company's interactions with Yale do not provide the FDA with any basis for exercising jurisdiction over the test. According to the response letter, Eberts says, "Yale's role in LabCorp's test is limited to licensing to LabCorp certain intellectual property...Yale has no control, contractual or otherwise, to influence the development, methodology, validation, performance characteristics, use, distribution or any other aspects of LabCorp's testing service."

However, Eberts goes on to say that in the interest of maintaining "positive and responsible relationships with regulatory agencies," LabCorp will voluntarily discontinue offering the test as of October 24, and requests a meeting with the FDA to discuss the issue.

The most recent warning letter may be found at:
http://www.fda.gov/foi/warning_letters/s6947c.htm

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