Test Summary

The risk of Ovarian Malignancy Algorithm (ROMA™) test is intended to aid in assessing the risk of ovarian cancer in women with a pelvic mass based on the patient's HE4 and CA125 levels, and their menopausal status. Women with ROMA™ levels above the cutoff have an increased risk of ovarian cancer. ROMA™ must be interpreted in conjunction with an independent clinical and radiological assessment.

The ROMA™ 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.

The CA125 and HE4 tests are performed using the Abbott ARCHITECT i2000SR unit. The values obtained with different assay methods cannot be used interchangeably due to differences in assay methods and reagent specificity.

The test is not intended as a screening stand-alone diagnostic or tumor monitoring assay. Tumor monitoring using HE4 and/or CA125 should be ordered separately.

The ROMA value is the result of a computation based on the HE4 and CA125 values observed.
Reference:
1. Moore RG, et al. A novel multiple marker bioassay utilizing HE4 and CA 125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol 2009; 112:40-6.

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