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FDA clears biomarker test for ovarian cancer
Date:9/6/2011

Approval last week by U.S. Food and Drug Administration (FDA) clears the path for nationwide use of tools that show the greatest specificity in estimating the risk of ovarian cancer in women with a pelvic mass.

The FDA granted 510(k) clearance for marketing and use of a combination of blood tests for proteins HE4 and CA125 with the Risk of Ovarian Malignancy Algorithm (ROMA). Research demonstrates that examining levels of HE4 and CA125 using the ROMA algorithm shows the highest accuracy in determining ovarian cancer risk in pre- and post-menopausal women.

The combination of blood tests and the ROMA algorithm were developed through the research of a team led by Richard G. Moore, MD, a gynecologic oncologist with the Program in Women's Oncology at Women & Infants Hospital of Rhode Island and director of the Center for Biomarkers and Emerging Technology. Dr. Moore is the lead author of a multi-center study investigating the use of HE4 and CA125 to determine ovarian cancer risk.

"Using ROMA with HE4 and CA125 significantly improves our ability to identify women who are at high or low likelihood of ovarian cancer when they present with an ovarian cyst or mass," explained Dr. Moore, who is also an assistant professor of obstetrics and gynecology at The Warren Alpert Medical School of Brown University.

The CA125 test has been the gold standard for monitoring patients diagnosed with ovarian cancer. The test, however, is limited in its sensitivity and specificity as well as its ability to detect all types of ovarian cancer. HE4 has been shown to be elevated in epithelial ovarian cancers, the most common type of ovarian cancer, but not elevated in many benign gynecologic diseases. Combining physician assessment with the independently validated ROMA algorithm more accurately stratifies benign disease from ovarian cancer in women who present with a pelvic mass. It also enables physicians to identify those patients at high likelihood of m
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Contact: Susan McDonald
slmcdonald@womenandinfants.org
401-681-2816
Women & Infants Hospital
Source:Eurekalert

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