OVA-1 is not securely established to be superior to Ca-125. Although there was a study determined that incorporating OVA1 in lieu of CA125 improved the sensitivity of the ACOG referral guidelines (77% to 94%) and the negative predictive value (87% to 93%) while decreasing specificity (68% to 35%) and negative predictive value (87% to 93%), with similar outcomes in premenopausal women and those with early-stage disease that enabled the researchers to detect almost 80% of all missed malignancies and more than 90% of missed epithelial ovarian cancers. Still, current American College of Obstetrics and Gynecology (ACOG) guidelines specify CA125 as the biomarker of choice in conjunction with other factors, including menopausal status, physical examination, family history, and imaging to determine patient risk levels and treatment plans.
The OVA1 test from Vermillion, Inc. measures the serum levels of five analytes—CA125, transthyretin (prealbumin), apolipoprotein A1, beta2 microglobulin, and transferrin—using two different immunoassay platforms, the Roche Elecsys for CA125 and the Siemens BNII for the four other analytes.
OVA1 /“Multivariate Index Assay” is included in The American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin Number 174, dated November 2016. This bulletin outlines ACOG’s “new” clinical management guidelines for adnexal mass management. The new guidelines now recommend that all obstetricians and gynecologists, in evaluating women with adnexal masses when the mass does not fulfill Level A criteria of a low risk transvaginal ultrasound (TVUS), should proceed with Level B clinical guidelines. Level B guidelines state that the physician should use risk assessment tools such as OVA1 (“Multivariate Index Assay”) as listed in the bulletin.
It is important to note that this refers to the OVA-1 tests itself not to a panel such as Aspira panel of 5 markers that includes OVA-1. Panels remain not supported by gudelines at this time.
The Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer. Committee Opinion No.477. American College of Obstetricians and Gynecologists. Obstet Gynecol; 117:742-6
Nolen BM, Lokshin AE. Biomarker testing for ovarian cancer: clinical utility of multiplex assays. Mol Diagn Ther. 2013;17(3):139-46.