Products and Services

ROMA®

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.

ABOUT ROMA®

ROMA, the combination of CA125 + HE4 tests, along with menopausal status, is used to help determine the likelihood of finding a malignancy on surgery in women who present with adnexal mass. Risk stratification helps ensure optimal patient care by promoting the triage of patients at high risk of ovarian malignancy to tertiary care centers with multidisciplinary teams that specialize in ovarian cancer.

The test can currently be ordered through Quest Diagnostics and LabCorp within the United States. Visit the U.S. website to learn more about ROMA.

For more information please contact us at customerservice@fdi.com.


HE4 now cleared in the U.S. as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer.
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