Test to detect ovarian Ca should not be on the market?

December 1, 2008

The OvaSure test has been withdrawn at the request of the FDA because it may prompt some women to have their ovaries removed unnecessarily.

The OvaSure test, introduced in June of this year by the Laboratory Corporation of America (LabCorp), has been withdrawn at the request of the Food and Drug Administration (FDA) because it may prompt some women to have their ovaries removed unnecessarily.

The FDA does not typically regulate tests that are developed and performed by a single laboratory, but this test, which promises to detect ovarian cancer early when it is still treatable, was developed at Yale University, not at LabCorp, and the materials for the test are not manufactured by LabCorp.

The test works by determining the levels of six proteins in a woman's blood sample. It then calculates the odds of that woman having ovarian cancer. Though it's apparently quite sensitive, concerns have been raised about its relatively high false-positive rate given that some clinicians might decide on prophylactic oophorectomy rather than careful clinical follow-up. The company is discussing the next steps with the FDA.