The Risk for Ovarian Malignancy Algorithm (ROMA) 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 likelihood of
finding malignancy on surgery. ROMA is 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
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. HE4 and CA125 values obtained with
different assay methods or kits cannot be used interchangeably.