The OVA1 blood test had a high chance of correctly identifying whether an ovarian mass was malignant prior to surgery, according to results of the OVA500 clinical trial. In a study of 494 patients, the test had 94% sensitivity in premenopausal women and 91% sensitivity in the early-stage ovarian cancer group, for an overall sensitivity of 96%. The OVA1 blood test had a negative predictive value of 98%.
OVA500 was designed to evaluate the test in 2 subgroups: those with early-stage ovarian cancer, where about 50% of patients have a normal CA125 level, and premenopausal women, who typically have a high incidence of benign cysts and a low incidence of ovarian cancer.
OVA1 is the first US Food and Drug Administration–approved blood test for ovarian cancer; the test has a high sensitivity to determine if cancer is present in women with an ovarian mass prior to surgery. OVA1 is an in vitro diagnostic test that combines results of 5 immunoassays using a proprietary algorithm to come up with a single numerical score indicating a woman’s likelihood of having ovarian cancer.
Vermillion, Inc, the diagnostic company that is marketing OVA1, released preliminary results of OVA500 and said that further details of the study have been submitted to a peer-review publication.
OVA500 follows a previous study published online in Obstetrics & Gynecology in March 2011 showing that use of OVA1 in place of the CA125 test correctly identified ovarian cancer 94% of the time versus 77% for CA125 in 516 women having surgery. The company hopes that results of OVA500 will support adoption and reimbursement for this blood test.