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Fujirebo Diagnostics Reports Published Pivotal Data For First Biomarker Combination Test

Fujirebo Diagnostics reported a published pivotal clinical trial that demonstrated the utility of combining the company’s 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 US 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) 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. This will increase these women’s chances of receiving optimal treatment.” The HE4 test and ROMA algorithm are the products 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.