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FDA Warns LabCorp About 'Misbranded' OvaSure Test

NEW YORK (GenomeWeb News) - Nearly one year after the US Food and Drug Administration slammed Exact Sciences for misbranding a genetic colorectal cancer screening assay it was developing with the Laboratory Corporation of America as a laboratory-developed test, LabCorp is facing regulatory action from the agency for the same violation for an ovarian cancer detection test it developed with Yale University.
The FDA issued a warning letter to LabCorp on Sept. 29 stating that LabCorp’s OvaSure test is “not within the scope of laboratory-developed tests over which the agency has traditionally exercised enforcement discretion.”
The warning letter follows an Aug. 7 letter, in which the FDA's Office of In Vitro Device Evaluation and Safety requested to meet with LabCorp to discuss the utility of OvaSure, which was developed at Yale University and launched in June, after it learned that the test's performance characteristics were based on results of a study that does not represent the intended treatment population.
Based on information collected by the FDA and data provided by the company at a Sept. 5 meeting, OIVD said it has determined that OvaSure is a test “designed, developed, and validated by investigators at Yale University and not LabCorp.”
Particularly, the FDA’s investigation has 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. The specific test parts and the manufacturer’s identity have been stricken from the publicly posted warning letter.
In clinical studies, Yale investigators used protein arrays to identify six candidate biomarkers to assess early-stage ovarian cancer in high-risk women, including leptin, prolactin, osteopontin, insulin-like growth factor II, macrophage inhibitory factory, and CA-125. These biomarkers were incorporated into a multiplex immunoassay.
In its warning letter, the FDA identifies OvaSure as a device under section 201(h) of the Food, Drug, and Cosmetic Act intended for diagnosing or treating disease, and therefore requiring marketing clearance or approval from the agency. “Because you do not have marketing clearance or approval from the FDA, marketing OvaSure is in violation of the law,” the agency determined, calling the device “adulterated” and “misbranded” as a result.
Eric Lindblom, LabCorp’s senior VP of investor and media relations, told GenomeWeb Daily News today that while the company is “disappointed about receiving the warning letter,” discussions are ongoing over possible next steps. “LabCorp shares the FDA's determination to help assure that patients are protected,” he stated.
However, Lindblom would not comment when asked whether the company felt any part of FDA’s regulatory guidelines regarding LDTs were confusing, particularly since this is the second time the company has been involved in a situation where a test being developed with a partner has been deemed by the agency as “misbranded.”
The FDA’s Oct. 11, 2007, warning letter to Exact Sciences similarly found its PreGen-Plus assay “adulterated” and “misbranded,” after the company failed to appropriately characterize the product it was developing with LabCorp.
The FDA’s action against Exact came after an inspection by the Centers for Medicare and Medicaid of LabCorp’s facilities revealed that PreGen-Plus was “designed, developed, validated, and marketed by Exact rather than a test that was developed and validated by LabCorp.” As a result, the FDA found that Exact’s test is not a laboratory-developed test that traditionally falls under the regulatory purview of CMS, but a medical device requiring premarket approval or clearance from the agency.
Last year, the FDA released a draft guidance explaining that in vitro diagnostic multivariate index assays are medical devices. Before this guidance, laboratory-developed tests, such as the OvaSure, were considered homebrews and overseen by the Centers for Medicare and Medicaid's less stringent CLIA rules.
Although in July, Exact had announced plans to submit a second version of the PreGen-Plus test to the agency for 510(k) clearance, the company suspended the validation study for the submission after facing potential delisting of its shares from the Nasdaq exchange.
Meanwhile, LabCorp in July launched ColoSure, a homebrew stool-based colon cancer test that uses PCR to detect the methylation of the Vimentin DNA marker. ColoSure is based on technology LabCorp licensed from Exact Sciences.
With regard to the OvaSure test, LabCorp has 15 working days from receipt of the warning letter to present to the FDA its plan to correct the violations identified by the agency.