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FDA Approves Blood Test for Ovarian Cancer


Coming during Ovarian Awareness Month is the news of the first FDA approved blood test to help detect ovarian cancer. The test is called OVA1.

A blood test OVA1 was developed by Vermillion Inc., headquartered in Fremont, Calif., in conjunction with researchers at The Johns Hopkins University in Baltimore.

The blood test OVA1 is recommended to be used by primary care physicians or gynecologists as an adjunctive test to help in making decisions regarding care in women 18 years and older who have a pelvic mass. It is not meant to replace other diagnostic and clinical procedures. It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer.

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OVA1 uses a blood sample to test for levels of five proteins that have been identified to change due to ovarian cancer. The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.

The FDA reviewed a study of 516 patients, including 269 evaluated by non-gynecological oncologists, which compared OVA1 results with biopsy results. When combined with pre-surgical information, such as radiography and other laboratory tests, results from the OVA1 tests identified additional patients who might benefit from oncology referral who were not identified using pre-surgical information alone.

“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,” said Jeffrey Shuren, M.D., J.D., acting director of the FDA’s Center for Devices and Radiological Health.

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