ROMA Calculation Tool- Using the Elecsys HE4 and CA125II with menopausal status to determine ovarian cancer risk

The ROMA Calculation Tool is a qualitative test for serum and plasma that combines the results of Elecsys® HE4, Elecsys® CA 125 II and menopausal status into a numerical score. The test is intended to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low probability of finding malignancy on surgery. The ROMA Calculation Tool using Elecsys® assays indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. ROMA Calculation Tool results must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay.