Biomarker testing for ovarian cancer: clinical utility of multiplex assays.

The improved detection of ovarian cancer at the earliest stages of development would confer a significant benefit in the therapeutic efficacy and overall survival associated with this devastating disease. The inadequate performance of currently used imaging modalities and the CA 125 biomarker test have precluded the establishment of screening programs and hindered the development of diagnostic tests for ovarian cancer. Two recently completed large clinical trials of ovarian cancer screening have reported findings of mixed impact, further clouding the issue. Considerable effort has been applied to the development of multiplexed biomarker-based tests and the most recent advances are discussed here. Within the clinical setting of pelvic mass differential diagnosis and triage, several significant advancements have been achieved recently, including the US Food and Drug Administration-approved Risk of Ovarian Malignancy Algorithm and OVA1 tests. The development and evaluation of those tests are described in this review. Thus while effective routine screening for ovarian cancer remains a lofty goal, advancement within the clinical management of pelvic mass diagnoses appears to be near at hand.