NEW YORK (GenomeWeb News) – Responding to a recent warning letter from the US Food and Drug Administration regarding alleged “misbranding” of its OvaSure test, Laboratory Corporation of America said that it will discontinue offering the test and seek a meeting with the agency.
The clinical lab firm said in a letter sent to FDA last week that it disagrees with the agency’s assertion that the OvaSure test, which is a biomarker-based multiplex immunoassay, is a medical device that is subject to regulation under the Federal Food, Drug, and Cosmetic Act. "The OvaSure test meets all applicable CLIA regulatory requirements," LabCorp said in the letter sent to Steven Gutman, director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety.
It also said that it does not agree with the FDA that its alliance with Yale University, which performed earlier development work and licensed the technology to LabCorp, provides the agency with “any basis for exercising jurisdiction over the test.”
The FDA’s Sept. 29 warning letter to LabCorp said that the OvaSure test was “designed, developed, and validated by investigators at Yale University and not LabCorp.”
Particularly, the FDA said that its investigation had found that the instructions for use and the performance characteristics for the test were developed by Yale investigators. Furthermore, the agency found that certain materials associated with the tests were manufactured by another entity.
But LabCorp disputes FDA’s claims, stating in its letter, “LabCorp has licensed intellectual property from Yale University; we did not purchase any products or materials from Yale.”
The letter, which was signed by LabCorp SVP and General Counsel F. Samuel Eberts, added, “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.”
LabCorp noted that its arrangement with Yale is similar to many others between academic research centers and clinical laboratories. “We are also unaware of any basis — and the Warning Letter cites none — for asserting that a laboratory assay is a device under the FDC Act because the laboratory allegedly did not establish the specifications for materials that the laboratory purchased from a third party vendor,” Eberts stated in the letter.
LabCorp said that it is “deeply concerned that the unprecedented position” taken by FDA regarding its relationship with Yale and the marketing of the OvaSure test “will stifle the ability of laboratories to provide innovative diagnostic tests.”
The firm said that even though it would discontinue offering the test as of Oct. 24, it requests a meeting with FDA officials to discuss its testing service and associated regulatory issues.
Industry observers have pointed out that FDA’s actions against LabCorp regarding OvaSure may further confound the agency's regulatory stance on IVDMIAs, particularly since the agency has yet to issue a final guidance on the matter. The final guidance is expected to be issued by FDA very soon, and was a continual topic of discussion — as was FDA’s warning letter to LabCorp — at last week’s Discovery 2 Diagnostics meeting in San Diego.