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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

his will increase these women's chances of receiving optimal treatment."

The HE4 test and ROMA algorithm are the product of research efforts aimed at identifying combinations of biomarkers to add sensitivity to the existing CA125 test, which is limited in its sensitivity and specificity as well as its ability to detect early stage EOC. The pivotal data provide important validation for the use of the HE4 test in combination with CA125 in estimating EOC risk in women presenting with pelvic mass and, when used in conjunction with other clinical methods, may help to ensure these women receive appropriate treatment.

Dr. Moore and his colleagues conducted a prospective, double-blind, multicenter trial involving 566 women with pelvic mass who were scheduled for surgical intervention. Blood samples were obtained from study participants to measure for levels of HE4 and CA125. Two separate algorithms for premenopausal and postmenopausal women stratified patients into low- and high-risk groups. All patients then underwent surgical removal of the pelvic mass. All tissue specimens were examined to verify the diagnoses made by study site pathologists.

The combination of HE4 and CA125 with the ROMA algorithm was found to be highly accurate in assigning patients to high- and low-risk groups, with 88.7% of EOCs and low malignant potential tumors correctly classified as high-risk. For the postmenopausal group the combination test had a sensitivity of 92.3%, a specificity of 74.7%, and a negative predictive value (NPV) of 92.6%. For the premenopausal group the combination test had a sensitivity of 76.5%, a specificity of 74.8%, and an NPV of 95.0%.

"Research demonstrates that patients who are treated by a gynecologic oncologist fare better than patients who are treated by a non-specialist. Any additional diagnostic tools that help the physician identify who is at a high risk of EOC may result in more optim
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SOURCE Fujirebio Diagnostics
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