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Early Screening Test for Ovarian Cancer on the Way?

By Sherry Baker

Although advocacy groups have pushed to raise public awareness of ovarian cancer, it often remains undiagnosed until it has progressed to an advanced stage, since its characteristic symptoms, such as bloating and abdominal pain, can be confused with those of other disorders. Existing tests such as transvaginal ultrasound or the blood test for CA-125—a tumor protein often elevated in women with ovarian cancer—are too unreliable and can lead to many false positives and false negatives. So neither is used routinely for screening, and they are reserved mostly for women known to be at high risk.

Now, however, a simple and more sensitive urine test appears to detect most ovarian cancers. Developed by ovarian cancer researcher Patricia Kruk, Ph.D., at the University of South Florida (USF) and the H. Lee Moffitt Cancer Center and Research Institute, it is a test that measures levels of a specific protein, Bcl-2, that is often overexpressed in a variety of tumors. This protein promotes cancer cell survival by preventing programmed cell death.

In a pilot study Kruk tested for the protein in the urine samples of 18 healthy volunteers, 38 women with benign gynecologic conditions and 35 patients in various stages of ovarian cancer. In patients with ovarian cancer, Bcl-2 levels were 10 times higher than in women without the disease or those with benign conditions such as fibroids or cysts. Elevated Bcl-2 levels were found in 92 percent of women with ovarian cancer, whereas elevated CA-125 levels identified only 68 percent of ovarian cancer patients.

Clinical development of the test is under way. GeoPharma Inc., a Largo, Florida-based company, signed an agreement in December with the USF Research Foundation to acquire worldwide patent rights for the test. So far, the ovarian cancer urine screening test has undergone one additional preliminary clinical study, but it won’t be available for widespread use until approved by the FDA. In the meantime, Kruk is “very enthusiastic” that the research will lead to a safe, routine screening test for ovarian cancer, akin to the Pap smear. “That is the ideal we are striving for,” she says.

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