The ROMA (Risk of Ovarian Malignancy Algorithm) test uses the results from simple blood tests, CA125 and HE4, to identify patients presenting with adnexal mass as high or low likelihood for finding malignancy on surgery. ROMA is a qualitative serum test that combines the results of HE4 EIA, ARCHITECT CA 125 II and menopausal status into a numerical score. HE4 is elevated in epithelial ovarian cancers (EOC), the most common type of ovarian cancer, but is not elevated in many benign gynecologic diseases.

The test is indicated for women who meet the following criteria: over age 18; presence of an ovarian pelvic mass 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 available through many clinical reference laboratories.

Fujirebio Diagnostics (Malvern, PA, USA) has received 510(k) clearance from the US Food and Drug Administration (FDA; Silver Spring, MD, USA) to market the company’s HE4 Test in an algorithm called ROMA (HE4 EIA + ARCHITECT CA 125 IITM) 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.

When physician assessment is combined with the independently validated ROMA algorithm, those patients can be identified at high likelihood of malignancy that should have their surgery performed by a gynecologic oncologist.

“The clearance of ROMA is a major advance for the gynecologist and will become an important component of the preoperative assessment of women presenting with a pelvic mass,” said Lee P. Shulman, MD, professor of obstetrics and gynecology, chief of the division of clinical genetics and codirector of the national ovarian cancer early detection program at Northwestern University (Chicago, IL, USA).

Related Links:
Fujirebio Diagnostics
US Food and Drug Administration
National Ovarian Cancer Early Detection Program at Northwestern University