Healthcare Professionals

How to Read the Test

ROMA™ Intended Use

For In Vitro Diagnostic Use Only.

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.

The clinical study conclusions are as follows8

  • In our study at a set specificity of 75% the sensitivity for epithelial ovarian cancer of the assay was 94% for all patients with a 98% Negative Predictive Value (NPV) for pre and post menopausal women

How to Read the Test

  • The following cut-points were used to reach our set level of specificity when using the HE4 EIA assay and the ARCHITECT CA125II assay.
    • Premenopausal:
      • ROMA Value ≥ 1.31 High likelihood of finding epithelial ovarian cancer
      • ROMA Value < 1.31 Low likelihood of finding epithelial ovarian cancer
    • Postmenopausal:
      • ROMA Value ≥ 2.77 High likelihood of finding epithelial ovarian cancer
      • ROMA Value < 2.77 Low likelihood of finding epithelial ovarian cancer