FDA Clears Vermillion's OVA1
The FDA has cleared Vermillion Inc.'s (Fremont, CA) OVA1 test to help detect ovarian cancer in pelvic masses requiring surgery. OVA1 identifies women who will benefit from referral to a gynecological oncologist for surgery, despite negative results from other clinical and radiographic tests for ovarian cancer, according to the FDA.
The FDA recommends OVA1 for women, 18 years and older, who are already selected for surgery because of their pelvic mass. It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer.
The OVA1 Test is an in vitro diagnostic multivariate index test combining the results of five immunoassays using a proprietary unique algorithm to produce a single numerical score indicating a women's likelihood of malignancy.
"When combined with other clinical information, the OVA1 biomarker panel can help assess the likelihood of malignancy of an ovarian tumor before surgery and facilitate decisions about referral to a gynecologic oncologist," said Frederick R. Ueland, MD, principal investigator of the prospective, multi-center OVA1 clinical trial; and associate professor gynecologic oncology at the University of Kentucky's Markey Cancer Center.
Quest Diagnostics has exclusive rights to offer the test to the clinical reference laboratory market in the U.S. for 3 years. The OVA1 Test will be available for physician use in the fourth quarter of this year.