OVA1, the first blood test cleared by FDA for aiding in the presurgical evaluation of a woman’s ovarian mass for cancer, is now available nationally through Quest Diagnostics Inc. With the availability of OVA1, physicians can assess, prior to a planned surgery, the likelihood that a woman’s ovarian mass is malignant in order to direct her to the most appropriate surgeon, promoting more favorable treatment outcomes. Vermillion Inc. developed the test in cooperation with Quest Diagnostics.

OVA1 is the first FDA-cleared protein-based in vitro diagnostic multi-variate index assays (IVDMIA). The test combines the results of five well-established protein biomarkers to produce a single numerical result to help a physician classify the likelihood that a woman’s mass is cancerous or benign.

In a prospective clinical study, OVA1, when combined with presurgical clinical and radiological assessments and used by non-gynecologic oncologists, detected 92% of malignant ovarian masses compared to 72% without OVA1. In addition, 14 of 20 woman who participated in the study whose cancer was missed by presurgical clinical and radiological assessments would have been identified as having malignant ovarian masses had OVA1 results also been evaluated prior to their surgeries.

FDA announced it had cleared OVA1 in September 2009, and Quest Diagnostics is the only national laboratory services provider to offer it broadly in the United States.