Patients and Caregivers

Risk of Ovarian Malignancy Algorithm (ROMA™)

Use ROMA to calculate the LIkelihood of epithelial ovarian cancer for patients scheduled for surgery

ROMA INTENDED USE

The Risk of Ovarian Malignancy Algorithm (ROMA™) is a qualitative serum test that combines the results of HE4 EIA, ARCHITECT CA 125 II™ and menopausal status into a numerical score.

ROMA 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.

PRECAUTION: ROMA (HE4 EIA + ARCHITECT CA125 II) should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of ROMA (HE4 EIA + ARCHITECT CA125 II) carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

Click here for the full ROMA package insert.