U.S. Food and Drug Administration Clears Vermillion's OVA1(TM) Test to Determine Likelihood of Ovarian Cancer in Women with P... ( MADISON N.J. and FR...)

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U.S. Food and Drug Administration Clears Vermillion's OVA1(TM) Test to Determine Likelihood of Ovarian Cancer in Women with Pelvic Mass

Date:9/11/2009

MADISON, N.J. and FREMONT, Calif., Sept. 11 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) today cleared the OVA1(TM) Test, the first blood test that, prior to surgery, can help physicians determine if a woman is at risk for a malignant pelvic mass. OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiological test results fail to indicate malignancy. The test was developed by Vermillion, Inc. (OTC: VRMLQ.PK), a molecular diagnostics company, in cooperation with Quest Diagnostics (NYSE: DGX), the world's leading provider of cancer diagnostics. Quest Diagnostics, which is a long-time investor in research and development of the OVA1 technology, has exclusive rights to offer the test to the clinical reference laboratory market in the U.S. for three years.

"When combined with other clinical information, the OVA1 biomarker panel can help assess the likelihood of malignancy of an ovarian tumor before surgery and facilitate decisions about referral to a gynecologic oncologist," said Frederick R. Ueland, M.D., principal investigator of the prospective, multi-center OVA1 clinical trial. Dr. Ueland is an associate professor gynecologic oncology at the University of Kentucky's Markey Cancer Center.

The OVA1 Test is an in vitro diagnostic multivariate index (IVDMIA) test that combines the results of five immunoassays using a proprietary unique algorithm to produce a single numerical score indicating a women's likelihood of malignancy. The OVA1 Test provides a new option in the pre-operative evaluation to help physicians assess if a pelvic mass is benign or malignant in order to help determine whether to refer a woman to a gynecologic oncolo
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SOURCE Quest Diagnostics Incorporated; Vermillion
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U.S. Food and Drug Administration Clears Vermillion's OVA1(TM) Test to Determine Likelihood of Ovarian Cancer in Women with P...( MADISON N.J. and FR...),Health