VRMLD Vermillion (MM)

- Company to Submit In Vitro Diagnostic Test to U.S. Food & Drug Administration - FREMONT, Calif., March 20 /PRNewswire-FirstCall/ -- Vermillion, Inc. (NASDAQ:VRMLD), a molecular diagnostics company, today announced preliminary results from a clinical trial evaluating its Ovarian Tumor Triage Test. 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.(1)(2) Vermillion's novel ovarian biomarker panel ruled out malignancy with approximately 95 percent certainty or negative predictive value. Negative predictive value is the probability that the patient is free of disease based on diagnostic evaluation. The panel also showed approximately 90 percent 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 United States. Vermilion plans to submit this in vitro diagnostic test to the U.S. Food and Drug Administration (FDA) for clearance. The Ovarian Tumor Triage Test provides information that may help improve outcomes for the hundreds of thousands of women in the United States who annually undergo surgery to remove a pelvic mass. While the vast majority of these tumors are benign, studies show that women with ovarian cancer who are initially operated on by a gynecologic oncologist have improved median and overall survival and have a better chance of being cured. Vermillion's ovarian tumor triage test utilizes a panel of biomarkers to help identify women at high risk of having cancer so that they can be referred directly to a gynecologic oncologist for their initial surgery. "The results from this clinical study hold promise for the large number of women diagnosed with an ovarian tumor each year," said Fred Ueland, M.D., principal investigator of the study and Associate Professor of Gynecologic Oncology at the University of Kentucky. "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." "These statistically significant results represent a major milestone in bringing our Ovarian Tumor Triage Test one step closer to patients who so desperately need a way of determining their risk of having a cancerous mass," said Gail Page, President and CEO of Vermillion. "Additionally, the results further confirm the company's significant investment in and commitment to our ovarian cancer diagnostics program. We look forward to publicly sharing the full data after making our submission to the FDA." About Vermillion's Ovarian Cancer Diagnostic Program In addition to developing a diagnostic test designed to distinguish between benign and malignant pelvic masses, Vermillion has a broad program of ovarian cancer diagnostic tests in development. Studies are underway to detect early-stage ovarian cancer, predict prognosis and recurrence, and identify women considered at high-risk for the disease. Vermillion's comprehensive 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. According to the American Cancer Society (ACS), approximately 22,430 new cases of ovarian cancer will be diagnosed this year, and 15,280 deaths will be reported as a result of the disease. When diagnosed at its earliest stages, ovarian cancer has a 5-year survival rate of 93 percent. However, only 19 percent of ovarian cancers are diagnosed before the tumor has spread outside the ovary. For late-stage disease, the 5-year survival rate falls to 18 percent. Ovarian cancer has up to a 90 percent 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 2008 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 ovarian cancer 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 ovarian cancer diagnostic products; (5) uncertainty of market acceptance of its ovarian cancer diagnostic 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. (1) Giede et al, Gynecol Oncol, 2005 Nov;99(2):447-61. (2) Earle et al, JNCI, 2006 Feb 1;98(3):172-80. DATASOURCE: Vermillion, Inc. CONTACT: Media, Daryl Messinger of WeissComm Partners, +1-415-946-1062, for Vermillion, Inc.; or Investors, Sue Carruthers of Vermillion, Inc., +1-510-505-2233 Web site: http://www.vermillion.com/

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