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

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.

Malvern, PA, USA - January 26, 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.

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