Study Presented at Society of Gynecologic Oncologists’ 40th Annual Meeting - on Women’s Cancer
FREMONT, Calif., Feb. 10 /PRNewswire-FirstCall/ -- Vermillion, Inc. , 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.
About Ovarian Cancer
Commonly known as the “silent killer,” ovarian cancer leads to approximately 15,000 deaths each year in the United States, according to the American Cancer Society. Approximately 20,000 new cases are diagnosed each year, with the majority in patients diagnosed with late stage disease where the cancer has spread beyond the ovary. The prognosis is poor in these patients, leading to the high mortality from this disease. A diagnostic test is needed that can provide adequate predictive value to stratify patients with a pelvic mass into high risk of invasive ovarian cancer versus those with low risk, as well as a screening test for the diagnosis of early-stage ovarian cancer, which is essential for improving overall survival in patients. Ovarian cancer has up to a 90% cure rate following surgery and/or chemotherapy if detected in stage 1.
About Vermillion
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in oncology, hematology, cardiology and women’s health. Vermillion is based in Fremont, California. Additional information about Vermillion can be found on the Web at http://www.vermillion.com.
Forward Looking Statements
This news release contains forward-looking statements that involve significant risks and uncertainties, including statements regarding Vermillion’s plans, objectives, expectations and intentions. These forward- looking statements are based on Vermillion’s current expectations. The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for such forward-looking statements. In order to comply with the terms of the safe harbor, Vermillion notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. There are no guarantees that Vermillion will succeed in its efforts to commercialize its ovarian cancer diagnostic tests in 2009 or during any other period of time. Factors that could cause actual results to materially differ include but are not limited to: (1) uncertainty in obtaining intellectual property protection for inventions made by Vermillion; (2) unproven ability of Vermillion to discover, develop, and commercialize diagnostic products based on findings from its disease association studies; (3) unproven ability of Vermillion to discover or identify new protein biomarkers and use such information to develop ovarian cancer diagnostic products; (4) uncertainty as to whether Vermillion will be able to obtain any required regulatory approval of its diagnostic products; (5) uncertainty of market acceptance of its products, including the risk that its products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for its products from third party payors such as private insurance companies and government insurance plans; and (6) other factors that might be described from time to time in Vermillion’s filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Vermillion expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Vermillion’s expectations or any change in events, conditions or circumstances on which any such statement is based, unless required by law.
CONTACT: Sue Carruthers of Vermillion, Inc., +1-510-226-2811
Web site: http://www.vermillion.com/
