Pivotal Data Published For First Biomarker Combination Test to Determine Risk of Ovarian Cancer in Women Who Present With P... ( Article in Gynecologic Oncology Suppo...)

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Pivotal Data Published For First Biomarker Combination Test to Determine Risk of Ovarian Cancer in Women Who Present With Pelvic Mass

Date:1/26/2009

Article in Gynecologic Oncology Supports Use of Fujirebio Diagnostics'

HE4 Test with CA125 for Risk Stratification of Women with Suspected Ovarian Cancer

MALVERN, Pa., Jan. 26 /PRNewswire/ -- A pivotal clinical trial published in the January 2009 issue of the journal Gynecologic Oncology demonstrated the utility of combining Fujirebio Diagnostics' HE4 and the CA125 test as an aid in estimating the risk of epithelial ovarian cancer in premenopausal or postmenopausal women presenting with pelvic mass. The HE4 test, which is under review by the U.S. Food and Drug Administration (FDA), was reported to successfully stratify patients into high- and low-risk groups when combined with CA125.

The combination test uses the results from two simple blood tests - CA125 and HE4 - and the Risk of Ovarian Malignancy Algorithm (ROMA(TM)) to identify patients at a high risk of having ovarian cancer. CA125 is the current gold standard for monitoring patients diagnosed with ovarian cancer. The HE4 assay was recently cleared by the FDA as an aid for monitoring recurrence of epithelial ovarian cancer (EOC), the most common type of ovarian cancer. Combining the HE4 and CA125 tests may enable physicians to pre-operatively identify those patients with a high risk of malignancy.

"Research suggests that ovarian cancer patients have better outcomes and improved survival when treated by gynecologic oncologists, surgeons that are trained and specialize in the treatment of patients with EOC," said Richard G. Moore, MD, Director of Medical Education, Program in Women's Oncology at Women and Infants' Hospital, and Assistant Professor, Obstetrics and Gynecology, Brown University, Providence, R.I, and lead author of the Gynecologic Oncology paper. "Combining measurements of HE4 and CA125 helps us to identify women who are at high risk of ovarian cancer when they present with an ovarian cyst or mass. T
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