Ovarian cancer test is under fire

OvaSure, the much bally-hooed new diagnostic blood test for early detection of ovarian cancer, is still causing much consternation.

In June, after it was introduced to the marketplace, doctors began taking sides on the risks and benefits offered by the test, which has yet to be validated by the U.S. Food and Drug Administration.

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In August, the FDA labeled the marketing of the individual tests as a potential public health risk.

September is National Ovarian Cancer Awareness Month, when physicians and researchers re-emphasize that ovarian cancer is the deadliest of all gynecological cancers and the fourth-leading cause of cancer deaths in American women.

“What women need to realize,” says John R. van Nagell, director of gynecologic oncology at the University of Kentucky Chandler Medical Center, “is that the test doesn’t diagnose anything. This predicts whether in the presence of ovarian tumors there is a risk of malignancy. What if it’s wrong?”

Suzi Shoemaker, one of the dozen members of the year-old Bluegrass Ovarian Cancer Support Group, says women are hungry for information about ovarian cancer because early detection can increase the chances of survivability to better than 92 percent. She says most women tend to think that annual Pap tests will detect ovarian cancer, but they don’t.

Van Nagell, director of the nation’s largest ovarian cancer screening trial, says there is no question that an early test is much sought and much desired. This one is simply “premature.”

He thinks there needs to be “additional research to validate the effectiveness of the test before it is offered outside the context of a research study.”

The issue, he says, seems to center on whether women would overly rely on the test and not seek additional testing, avoid necessary surgery or insist on unneeded surgery.

Work on the OvaSure test has been conducted at Yale University, and it is manufactured through Laboratory Corp. of America Holdings Inc. Both claim 90 percent to 99 percent reliability of test results. Those numbers are at issue with the FDA as well.

Other test manufacturers have been working on a similar detection method.