New data presented on Saturday during the plenary session at the Society of Gynecologic Oncologists' 40th Annual Meeting on Women's Cancer demonstrated the accuracy of the HE4 test - in combination with CA125 blood test results and the Risk of Ovarian Malignancy Algorithm (ROMA(TM)) - in assessing the risk of ovarian cancer in women who will undergo surgery to remove a pelvic mass compared to the Risk of Malignancy Index (RMI). The data show that ROMA achieved greater sensitivity in distinguishing a benign mass from epithelial ovarian cancer (EOC) in premenopausal and postmenopausal women, and more accurately assigned patients with EOC to a high-risk group compared with RMI.

These results have important implications for the more than 280,000 American women who will be diagnosed with a pelvic mass over the course of a year. By combining the biomarkers HE4 and CA125 along with ROMA, the Fujirebio Diagnostics test appears to be more sensitive than the traditional RMI, which utilizes CA125 and imaging as well as menopausal status to evaluate the risk of ovarian cancer. CA125 is the current gold standard for monitoring patients diagnosed with ovarian cancer, but is less sensitive when used as a risk stratification tool, especially in premenopausal women, as elevated CA125 blood levels can result from non-cancerous conditions.

"These data confirm the utility of HE4 in the assessment of women with an ovarian cyst or pelvic mass, and can provide physicians with an accurate, objective tool to classify patients into high- and low-risk groups before surgery," said Richard Moore, MD, Assistant Professor of Obstetrics and Gynecology at Women and Infants Hospital and the Alpert Medical School at Brown University in Providence, RI…