Fujirebio Diagnostics announced that it has received 510(k) clearance from the FDA to market the company’s HE4 Test in an algorithm called ROMA to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery.
The ROMA (Risk of Ovarian Malignancy Algorithm) test uses the results from simple blood tests, CA-125 and HE4, to identify patients presenting with adnexal mass as being at high or low likelihood for finding malignancy on surgery. HE4 has been shown to be elevated in epithelial ovarian cancers but is not elevated in many benign gynecologic diseases. Combining physician assessment with the independently validated ROMA algorithm enables physicians to identify patients at high likelihood of malignancy who should have their surgery performed by a gynecologic oncologist.
“This combination test will allow physicians to identify those patients who should be treated by a gynecologic oncologist and equally important allow women with benign disease to stay in their communities with the physician who knows them best. It will change the way doctors diagnose and treat ovarian cancer,” said Richard G. Moore, MD, Associate Professor of Obstetrics and Gynecology at the Alpert School of Medicine at Brown University in Providence, Rhode Island. Dr. Moore is the lead researcher for the team that developed ROMA and author of two multicenter studies investigating the use of HE4 and CA-125 and ROMA.
A large body of published, multinational, peer-reviewed clinical evidence supports the use of the HE4 test in combination with the CA-125 test.
Its utility as a stratification tool is supported by results from a prospective, double-blind, multicenter trial involving 472 women with pelvic mass who were scheduled for surgical intervention.
Data from a study of 472 patients presented at this year’s Annual Meeting of the Society of Gynecologic Oncologists and published in the August 2011 issue of Obstetrics and Gynecology show that ROMA alone was highly accurate in assigning a combined pre- and postmenopausal patient population to likelihood groups, with 93.8% of epithelial ovarian cancers correctly classified as high likelihood.1 Looking at the postmenopausal group, ROMA had a sensitivity of 92.3%, a specificity of 76.0%, and a negative predictive value of 97.4%. Looking at the premenopausal group, ROMA had a sensitivity of 100%, a specificity of 74.2%, and a negative predictive value of 100%. ■
1. Moore RG, Miller MC, Disilvestro P, et al: Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass. Obstet Gynecol 118(2, Part 1):280-288, 2011.