The FDA has issued 510(k) clearance to market HE4 Test in an algorithm (ROMA [HE4 EIA + ARCHITECT CA 125 II]; Fujirebio Diagnostics), which aids 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.
This Risk of Ovarian Malignancy Algorithm test uses the results from CA 125 and HE4 blood tests to identify patients presenting with adnexal mass as high or low likelihood for finding malignancy on surgery.
Approval was based on data from a study of 462 patients, which showed that, when used in conjunction with the methods a physician would normally use to assess likelihood of ovarian cancer in a combined pre- and postmenopausal patient population, ROMA had a sensitivity of 88.4%, a specificity of 67.2%, and a negative predictive value of 96.2%.
The ROMA test is indicated for women who are older than 18 years, have an ovarian pelvic mass for which surgery is planned, and have not yet been referred to an oncologist. The test must be interpreted in conjunction with an independent clinical and radiological assessment, according to the manufacturer.