Lack of Data and FDA Compliance Halts Sale of Ovarian Cancer Test

By Rachel Walden |

The National Women’s Health Network recently released a health alert, “Don’t be Fooled by Ovasure,” critical of the product OvaSure, a blood test promoted for ovarian cancer detection and available from LabCorp since June. NWHN gives a brief summary of the problems related to OvaSure, including a lack of data indicating that it could detect early disease and the problem of false positive tests that could lead to unnecessary procedures.

Following the initial release of the test earlier this year, the Ovarian Cancer National Alliance issued a press release on the test, expressing similar reservations until further data becomes available:

“We look forward to the publication of Phase III trial data from the study later this year validating the test. This may, indeed, be a breakthrough in the detection of ovarian cancer,” said Dr. Karen Orloff Kaplan, Sc.D., Executive Director. She added that “we must wait for the data to come in before we rely on this test.”

A New York Times piece from August also highlights the data problem, explaining that “The Society of Gynecologic Oncologists almost immediately issued a statement saying it did not believe the test had been validated enough for routine use.” One gynecologic oncologist interviewed for the story called it “[the] industry trying to capitalize on fear.”

The National Women’s Health Network also notes that LabCorp has been informed by the FDA that it has not met the appropriate approval requirements for the OvaSure product. On August 7, the FDA issued a letter advising the company that:

“Based on the available information, we do not believe the scientific community would consider the reported study sufficient to establish performance characteristics of a test in ‘high risk women who might have ovarian cancer’, i.e., in a clinical setting, as claimed in your intended use and promotional materials.”

The FDA concluded: “we believe you are offering a high risk test that has not received adequate clinical validation, and may harm the public health.” An additional warning letter sent September 29 notes that the Agency had reviewed materials sent to them on the test, finding that the product is a device requiring marketing approval from the FDA prior to sale, and as such, “According to our records, no such determination has been made for OvaSure™. Because you do not have marketing clearance or approval from the FDA, marketing OvaSure™ is in violation of the law.”

Although LabCorp expressed disagreement with the FDA’s findings, the company halted sale of the product at the end of last month.

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One Comment

  1. Margie says:

    Ovarian cancer is really scary because there is no test for it or even an exam. It seems to be purely luck if caught. I also think it is a type of cancer that is sorely neglected. Breast cancer gets all the attention and ovarian cancer is like the ugly stepchild.