Diagnostic testing services provider Quest Diagnostics and Vermillion, which develops molecular diagnostic tests, recently received Food and Drug Administration approval for a test to assess the likelihood that a woman diagnosed with a pelvic mass has ovarian cancer, as opposed to a benign tumor.

The OVA1 test uses a proprietary algorithm to evaluate five biological markers that, if found in a patient's blood, could indicate the presence of a malignant tumor. OVA1 factors in other data, such as whether the patient is pre- or post-menopausal, and produces a numerical score indicating the likelihood of malignancy, says Dr. Jon Cohen, Quest senior VP and chief medical officer. Patients likely to have ovarian cancer can then be referred to surgeons who specialize in gynecologic cancers, since they tend to have better outcomes than regular surgeons treating the disease, Cohen says.

Prior to the OVA1 test, surgical biopsy was the only way to determine if a pelvic mass was malignant. Women often would go to a general surgeon for a biopsy and, if it was found to be malignant, would sometimes immediately have the tumor removed by that surgeon as part of the same procedure. As a result, only about a third of women having this surgery have been under the care of gynecologic oncologists--not a good situation since ovarian cancer is the leading cause of death among gynecologic cancers in the United States.

Marianne Kolbasuk McGee has been reporting on healthcare IT for InformationWeek for more than a decade. See more of her work on Informationweek Healthcare.

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