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Vermillion Releases Data from 494-Patient Study Supporting OVA1

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Vermillion this week released data from a new prospective, multi-center clinical study on its ovarian cancer diagnostic OVA1 that the company said "confirms and extends" previous studies supporting use of the test.

The 494-patient study, called OVA500, was conducted by Robert Bristow, director of gynecological oncology services at University of California, Irvine, Healthcare, and found that OVA1 identified ovarian cancer in women with an adnexal mass with sensitivity of 96 percent and specificity of 51 percent.

The study, Vermillion said, focused in particular on two subgroups: "women with early-stage ovarian cancer, where approximately half of patients have a normal CA125 level, and pre-menopausal women, where the incidence of ovarian cancer is low and incidence of benign cysts is high."

The test demonstrated 91 percent sensitivity with 61 percent specificity for early-stage, pre-menopausal women.

The company said it has submitted additional details from the study for peer-reviewed publication and aims to use the data to drive adoption and reimbursement of the test.

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