Multianalyte assay systems in the differential diagnosis of ovarian cancer.

INTRODUCTION: The efficient triage of women diagnosed with a pelvic mass presents a current area of unmet need. Unnecessary surgical intervention performed on patients at a decreased risk of malignancy represents a significant source of preventable morbidity, anxiety and cost. Likewise, delayed or overlooked referral of patients harboring malignant tumors is strongly associated with diminished outcomes. Current tools including imaging modalities and the CA 125 blood test are of insufficient accuracy to overcome these challenges. The use of multianalyte assays systems which include additional biomarkers capable of complementing the performance of CA 125 may offer the best hope of improvement. AREAS COVERED: Recent findings regarding the use of multianalyte biomarker panels for the differential diagnosis of a pelvic mass are reviewed and discussed. Particular attention is paid to to the FDA approved ROMA and OVA1 tests. The development, validation, recent evaluation and comparative performances of these two tests are reviewed in detail. EXPERT OPINION: The performances achieved by the ROMA and OVA1 diagnostic tests represent significant milestones in the application of multianalyte assay systems into standard clinical practice. The overall impact and cost-effectiveness of widespread clinical use of these tools remains to be evaluated.