LabCorp Halts Sale Of OvaSure

Main Category: Ovarian Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 Oct 2008 - 8:00 PDT

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Laboratory Corporation of America disclosed in a filing with the Securities and Exchange Commission that effective Friday, it would halt sales of OvaSure, a blood test for early detection of ovarian cancer, the New York Times reports. According to the Times, the case "has raised questions about the degree to which the FDA can or should regulate diagnostic tests."

In June, LabCorp began selling OvaSure as an early-detection test for women with a high risk of ovarian cancer under a rule that exempts tests from FDA regulation that are developed and marketed by a single company (Pollack, The New York Times, 10/25). On Sept. 29, FDA sent a letter to LabCorp saying that the company did not qualify for the exemption because the test was developed at Yale University, not at LabCorp, and uses materials not manufactured by LabCorp. The letter ordered LabCorp to "take prompt action to correct these violations" (Daily Women's Health Policy Report, 10/10).

LabCorp in an Oct. 20 letter to FDA -- included in the SEC filing -- said that it disagrees with FDA's "unprecedented position" and implied that the decision would hamper clinical innovation. However, the company will stop offering OvaSure to help it maintain "positive and responsible relationships with regulatory agencies," the letter said.

In the letter, LabCorp general counsel Samuel Eberts wrote, "Many tests currently offered by laboratories were initially developed by academic researcher centers. Restricting the ability of laboratories to utilize information and knowledge generated by academic researchers will have a negative impact on the availability of diagnostic tests that offer substantial health care benefits." Eberts also requested a meeting with FDA. According to the Times, the OvaSure case has heightened discussion about FDA's role in regulating diagnostic tests, and some experts have said the test was not proven effective (New York Times, 10/25).

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