NEWS: Vermillion Presents Critical Data From Its OVA1 Clinical Trial
9:00a ET February 10, 2009 (PR NewsWire)
Study Presented at Society of Gynecologic Oncologists' 40th Annual Meeting - on Women's Cancer
FREMONT, Calif., Feb. 10 /PRNewswire-FirstCall/ -- Vermillion, Inc. (OTC Bulletin Board: VRML), a molecular diagnostics company, presented data from its prospective OVA1 clinical trial at the Society of Gynecologic Oncologists' (SGO) 40th Annual Meeting on Women's Cancer in San Antonio, TX (Poster 196). The study entitled "A biomarker panel for distinguishing between malignant and benign ovarian tumors" was co-authored by Fred Ueland, MD, Associate Professor of Gynecologic Oncology at the University of Kentucky and Principal Investigator of the OVA1 clinical trial, and Zhen Zhang, PhD, Associate Professor of Pathology at the Johns Hopkins University School of Medicine as well as Vermillion scientists.
Details of the poster are available in the attached link "A biomarker panel for distinguishing between malignant and benign ovarian tumors." The primary aim of the study was to determine the ability of our proprietary OvaCalc algorithm to estimate the risk of malignancy in pre and postmenopausal women who are scheduled for surgery with an ovarian mass. The data demonstrates that the OvaCalc algorithm can effectively identify women with a higher likelihood of malignancy. Within the study population, the OvaCalc algorithm also detected 90% of Stage I epithelial ovarian cancer cases and 100% of stage 2-4 cancers while maintaining a greater than 90% negative predictive value among both premenopausal and postmenopausal patients.
"We are extremely pleased with the significant results of the OVA1 prospective clinical trial. A major strength of the OVA1 prospective clinical trial was its inclusion of patients seen at a variety of clinical settings where the intended patient population typically undergoes a gynecological examination with radiological and clinical testing prior to surgical intervention. The 27 sites were demographically mixed to include, for example, large and small medical centers (universities/community hospitals), small gynecology/obstetrics groups, gynecology/oncology practices, and subjects from HMO groups. This study demonstrated with statistical significance the effectiveness of the OVA1 test in estimating the risk of malignancy in pre and postmenopausal women who are scheduled for surgery with an ovarian mass," said Gail S. Page, President and CEO.
"Research demonstrates that patients who have initial surgery performed by a gynecologic oncologist fare better than patients who are treated by a non-specialist. Any additional diagnostic tools that help the physician identify who is at a high risk of EOC may result in more optimal referral patterns and improved outcomes," said Karen Orloff Kaplan, Sc.D., Chief Executive Officer of the Ovarian Cancer National Alliance.
About Vermillion's Ovarian Cancer Diagnostic Program
Vermillion has multiple ovarian cancer diagnostic tests in development. The most advanced of Vermillion's programs is the OVA1 test, which is designed to utilize a panel of biomarkers to help identify women with a higher likelihood of malignancy so they can be referred to a gynecologic oncologist for their initial surgery. Vermillion filed a 510(K) Application with the U.S. Food and Drug Administration for its OVA1(TM) Test in June 2008.
Additionally, studies are underway to develop tests with the capability of detecting early-stage ovarian cancer, predicting prognosis and recurrence, and identifying women considered at high-risk for the disease.
Vermillion's premier diagnostic development program is being conducted with several leading collaborators at The Johns Hopkins School of Medicine, The University of Texas M.D. Anderson Cancer Center, Rigshospitalet (Copenhagen), and the University of Kentucky.
The Company's OVA1 test is part of a strategic alliance with Quest Diagnostics to jointly develop and commercialize diagnostic tests.
AI
