Vermillion’s ovarian tumor test trial meets study end point

The study met its primary endpoints, demonstrating that the test successfully stratifies women with pelvic masses into high- and low-risk categories to determine whether the patient should be referred to a specialist prior to surgery. These results indicate that the use of this test could significantly increase the percentage of high-risk cases referred to the appropriate specialist for treatment, ultimately improving survival rates.

Vermillion’s novel ovarian biomarker panel ruled out malignancy with approximately 95% certainty or negative predictive value. The panel also showed approximately 90% sensitivity for detecting malignant ovarian tumors. The prospective clinical trial was one of the largest ever conducted and assessed more than 550 patients with a confirmed adnexal mass at 27 clinical trial sites in the US. Vermilion plans to submit this in vitro diagnostic test to the FDA for clearance.

Fred Ueland, principal investigator of the study, said: “A test that informs women and their physicians of the risk of malignancy before surgery is an important advancement, and will help guide women to the appropriate specialist.”