Ovarian Tumor Triage Test Identifies Women Requiring Surgery

A tumor triage test helps to assess risk of ovarian cancer in the hundreds of thousands of women who require surgery for ovarian tumors each year.

The ovarian tumor triage test utilizes a panel of biomarkers to help identify women with cancer so they can be referred directly to a gynecologic oncologist for their initial surgery, thus improving survival rates and potentially reducing the number of second surgeries performed.

Called Ova1, the tumor triage test underwent a prospective clinical trial and met its primary endpoints, indicating that the test is capable of stratifying women with pelvic masses into high- and low-risk categories to help determine whether the patient should be referred to a specialist prior to surgery. The clinical trial was one of the largest ovarian cancer studies ever conducted and assessed more than 550 women with a confirmed adnexal mass at 27 clinical sites in the United States. Additionally, the trial was the culmination of more than eight independent studies in more than 2500 women.

Vermillion (Fremont, CA, USA), a molecular diagnostics company, has filed a 510(k) application with the U.S. Food & Drug Administration (FDA; Rockville, MD, USA) for its Ova1 ovarian tumor triage test.

This is an important milestone for Vermillion and a significant step toward the commercialization of Ova1. "We are pleased with the results of the trial and look forward to discussing the significance of our data and our commercialization strategy in an upcoming investor roundtable, planned for July [2008],” said Gail Page, president and CEO of Vermillion. "We also look forward to receiving regulatory clearance from the FDA and making Ova1 available to the hundreds of thousands of women who could benefit considerably from the test.”


Related Links:
Vermillion
U.S. Food & Drug Administration