Validation of the Cut-points Recommended for ROMA Using the Roche Elecsys CA125 and HE4 Assays

Assessing the risk of malignancy in patients with a pelvic mass helps triage women suspected of ovarian cancer to specialized gynecologic oncologists to improve treatment outcomes. To this end, several algorithms have been proposed; most notably, the Risk of Ovarian Malignancy Algorithm (ROMA) based on CA125, HE4, and menopausal status. However, appropriate decision cut-points for the ROMA score depends on the choice of analytical assays used. This study validates the use of the Roche Elecsys CA125 and HE4 assays for ROMA calculation in a cohort of 207 women who presented to Mayo Clinic with a pelvic mass. Results were compared to a definitive histologic diagnosis in each case. Clinical performance of ROMA scores derived using these assays was similar to stated claims and indicates that recommended cut-points are acceptable for clinical use.