Gynecologic Oncology, the prestigious medical journal of the Society for Gynecologic Oncology, has published the second prospective clinical study of OVA1® which demonstrated the positive performance of the multi-biomarker test in the triage of early-stage ovarian cancer.
Vermillion, Inc. (NASDAQ: VRML), the molecular diagnostics company which developed and currently markets the test, had reported positive top-line results of the study in July. Referred to as "OVA500," the study confirms and extends the findings of the first OVA1 pivotal study published last year in Obstetrics & Gynecology by Dr. Fred Ueland of the University of Kentucky.
The OVA500 results were published online by Gynecologic Oncology on November 22 in the article, "Ovarian Malignancy Risk Stratification of the Adnexal Mass Using a Multivariate Index Assay." The article was authored by Dr. Robert E. Bristow, the director of Gynecologic Oncology Services at UC Irvine Healthcare and former director of gynecologic oncology at Johns Hopkins.
The multi-center study investigated OVA1 performance in the pre-surgical detection of malignancy among 494 women prospectively enrolled from non-gynecologic oncology practices. Sensitivity across all types of ovarian cancers was 96% when OVA1 was added to routine clinical assessment, and this result was nearly identical to the first pivotal study. Importantly, within the test group OVA1 identified 83% of cancers missed by clinical assessment and 71% of cancers missed by CA125.
"The publication of the OVA500 study advances our strategic plan to increase physician adoption and payer coverage, leading to incorporation of OVA1 into the standard of care for ovarian cancer," said Bruce A. Huebner, Vermillion's interim CEO. "The publication of a second independent prospective, multi-center study such as this is considered critically important by many doctors, payers and professional societies. Test data generated from nearly 500 patients enrolled at 27 centers, including 17 new sites, demonstrated the robust performance of OVA1 across diverse geographic settings."
"Both our initial clinical study and OVA500 showed that all combined modalities used in routine clinical assessment failed to predict cancers at a rate of more than 24%. But when adding OVA1, the rate of cancers missed was little more than 4% in each study," continued Huebner. "Now more than ever, we believe the evidence warrants that OVA1 be incorporated into a standardized pre-surgical assessment of adnexal masses."
Dr. Bristow commented: "New tools for the sensitive detection and referral of ovarian cancer are badly needed, given the more than 15,000 women who die every year from this disease in the U.S. The OVA500 study confirmed in a new patient cohort that about 96% of malignancies were detected by adding OVA1 to clinical assessment, and these included 91% of early-stage disease and 94% of premenopausal cancers. At the same time, the majority of subjects with benign disease were classified as low risk, with 98% of negative tests resulting in a benign pathology finding. Thanks to diagnostic advances like OVA1, there is real hope that the majority of women with ovarian cancer will undergo surgery by a qualified gynecologic oncologist, which is one of the most powerful determinants of survival."