Vermillion Completes Clinical Trial Enrollment for Ovarian Cancer Triage Test
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Vermillion, Inc. has announced that it has completed clinical trial enrollment for its ovarian cancer triage test. The prospective clinical trial was designed to demonstrate that the ovarian triage test is a useful adjunct for distinguishing benign from malignant ovarian tumors. 550 patients were enrolled at 27 clinical trial sites.
"Enrollment completion marks a significant milestone for our company, our ovarian cancer diagnostics program, our shareholders and for potential patients who may benefit from improved treatment when diagnosed with a pelvic mass," said Gail S. Page, President and CEO, Vermillion, Inc. "We are now compiling these data for submission to the FDA for in vitro diagnostic clearance and expect to report top-line results in December."
Studies show that women with ovarian cancer who are initially operated on by a gynecologic oncologist or at specialist medical centers survive longer and have a better chance of being cured, compared to those whose surgeries are performed by a non-specialist. The ovarian tumor triage test is designed to assist physicians in determining whether patients should be referred to specialists prior to their initial surgery.
