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Ovarian Cancer
Pivotal Data Published for First Biomarker Combination Test to Determine Risk of Ovarian Cancer in Women Who Present With Pelvic Mass
February 10th, 2009
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...
Source: Cancer Weekly (2009-02-10)
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