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Fujirebio Diagnostics` Risk Of Ovarian Malignancy Algorithm(ROMA) In Combination With Biomarker Demonstrates Accuracy In Detecting Ovarian Cancer

Fujirebio Diagnostics announced that a new data has been presented during the plenary session at the Society of Gynecologic Oncologists’ 40th Annual Meeting on Women’s Cancer. The data demonstrated the accuracy of the HE4 test—in combination with CA125 blood test results and the Risk of Ovarian Malignancy Algorithm (ROMA)—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. 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. “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.