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Biomarker Combination and Risk of Ovarian Malignancy Algorithm (Roma(TM)) Demonstrates Accuracy in Detecting Ovarian Cancer
Date:2/11/2009

n Providence, RI. "By using a test with greater accuracy that is not reliant on subjective imaging, physicians can now identify those patients that are at a high risk for having a malignancy, potentially improving clinical outcomes for these women."

Dr. Moore presented data from a prospective, double-blind, multicenter trial of 457 evaluable women diagnosed with a pelvic mass. Blood samples were obtained from study participants to measure for levels of HE4 and CA125. Two separate algorithms for premenopausal (n=212) and postmenopausal (n=245) women stratified patients into low- and high-risk groups. All patients then underwent surgical removal of the pelvic mass, and if a patient was diagnosed with an EOC, surgical staging was required by protocol. All tissue specimens were examined to verify the diagnoses made by study site pathologists.

There were 123 patients determined to have an invasive EOC and 22 patients had a low malignant potential or borderline tumor. The remainder had various benign tumors. ROMA stratified 94.3% of the women with an invasive EOC correctly into a high-risk group.

Additionally, ROMA demonstrated greater accuracy in detecting ovarian cancer across all stages of disease, including early stage disease where 85.3% of the invasive EOCs were correctly identified.

"Currently, only 20% of women with ovarian cancer are diagnosed in the early stages, when the five-year life expectancy exceeds 90%," commented Dr. Moore, who is also the Director of Medical Education for the Program in Women's Oncology and a gynecologic oncologist at Women & Infants' Hospital in Providence, RI.

About HE4

HE4 in a manual format is currently FDA-cleared for monitoring recurrent or progressive disease in patients with EOC, and CE-marked in Europe as an aid in estimating the risk of EOC in premenopausal or postmenopausal women presenting with a pelvic mass. T
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SOURCE Fujirebio Diagnostics, Inc.
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