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. 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.
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