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Vermillion's Ovarian Cancer Test Gets FDA OK

NEW YORK (GenomeWeb News) – Vermillion has received clearance from the US Food and Drug Administration to market its OVA1 test for helping physicians determine if a woman is at risk for a malignant pelvic mass prior to surgery.

The Fremont, Calif.-based firm developed the test in collaboration with Quest Diagnostics, which has exclusive rights to offer the test to the clinical lab market in the US for three years. It expects the test to be on the market in the fourth quarter of this year.

The OVA1 test is an in vitro diagnostic multivariate index test that combines the results of five immunoassays using a proprietary unique algorithm to produce a single numerical score indicating a women's likelihood of malignancy.

FDA noted in a release today that the OVA1 test "should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures."

"Physicians often do not know if a woman's pelvic mass is malignant or benign until she undergoes surgery," Jon Cohen, chief medical officer and senior VP of Quest Diagnostics, said in a statement. "The OVA1 Test is the first FDA-cleared blood test to help clinicians determine whether to refer a woman to a gynecologic oncologist or have a gynecologic oncologist present at the time of surgery. We believe this test will help drive more favorable patient outcomes."

The firms noted that Madison, NJ-based Quest is now the only firm offering FDA-cleared tests for ovarian cancer in the pre- and post-surgical settings. In addition to offering the OVA1 test, Quest also sells an FDA-cleared test for monitoring the recurrence of epithelial ovarian cancer.