New ovarian Ca screening test to debut next month: targets high-risk women: critics concerned that OvaCheck's accuracy rates remain unpublished.(News)

A new test to screen patients at high risk for ovarian cancer is slated for release next month.

But critics say the test, to be marketed as OvaCheck, may not replicate the high accuracy rates shown in studies of a similar test on which it is based.

OvaCheck, developed by Correlogic Systems Inc., identifies a very specific metabolite pattern that has been found to occur in the blood of women with ovarian cancer, even at very early stages.

A similar test, which involved a different molecular pattern, was the subject of a landmark 2002 study. That study of 216 women showed that the protein pattern--based test had a specificity of 95% and a sensitivity of 95%, with a positive predictive value of 94% (Lancet 359 [9306]:572-77, 2002). OvaCheck was developed on the basis of this test.

However, OvaCheck's rush from research to market, and the fact that its accuracy rate remains unpublished, worry Dr. Robert Bast Jr., who is vice president for translational research at the University of Texas M.D. Anderson Cancer Center, Houston.

"With any new test, it's crucial that we have a large enough patient sample to know what the true value is," he said. "There is no published data on the accuracy of this test and until there is, I don't see how anyone can recommend its use."

Correlogic and LabCorp, one of the two national labs that will process the test, are working together, validating the test with a series of blind samples.