Monday, September 14, 2009
MONDAY, Sept. 14 (HealthDay News) -- On Sept. 11, the U.S. Food and Drug Administration cleared OVA1, a test that helps detect ovarian cancer in women with pelvic masses requiring surgery. OVA1 was developed by Vermillion Inc., headquartered in Fremont, Calif., in conjunction with researchers at Johns Hopkins University in Baltimore.
The FDA reviewed a study of 516 women, including 269 patients who were evaluated by non-gynecological oncologists, comparing OVA1 results with biopsy results. It was determined that, even if other radiographic and clinical tests have negative results, OVA1 could help identify women who might benefit from referral to a gynecological oncologist for surgery. OVA1 uses a blood sample to test for levels of five proteins that change because of ovarian cancer.
In the news release, the FDA emphasized that the test is only for women age 18 years and older who have already been selected for surgery because of pelvic masses, and it should complement -- not replace -- other tests. According to the agency, if other test results suggest cancer, it is appropriate to refer a patient to an oncologist even if OVA1 results are negative.
"Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications," Jeffrey Shuren, M.D., acting director of the FDA's Center for Devices and Radiological Health in Atlanta, said in a statement.
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