August 26th, 2008

The New York Times reports today on a new blood test that is available to detect ovarian cancer in women at an extremely early stage.  However, the Food and Drug Administration, among other experts say that the test is premature, and not yet accurate enough.

When ovarian cancer is detected in it’s earliest stages more than 90 percent of women will live more than five years.  Unfortunately, most cases are currently not caught that early.  Advocates of the new test, Ovasure, say that since the test detects the cancer earlier, it will save lives.  Others say that the test has not been thoroughly developed and tested yet.  Critics worry that since Ovasure could has a false positive rate of about 1 percent  (identifying cancer when it is not really there) it will cause unneeded anxiety and painful surgeries for women that don’t even have cancer.

The Times continues, “OvaSure’s debut also raises questions about whether greater regulation is needed to assure the validity of a trove of sophisticated new diagnostic tests that are entering the market and are being used as the basis for important treatment decisions. OvaSure did not go through review by the Food and Drug Administration because the agency generally has not regulated tests developed and performed by a single laboratory, as opposed to test kits that are sold to laboratories, hospitals and doctors. (All OvaSure blood samples are sent to LabCorp for analysis.)”