FREMONT, Calif., Oct. 29 /PRNewswire-FirstCall/ -- Vermillion, Inc. (OTC Bulletin Board: VRML) announced today that it has agreed with Quest Diagnostics to extend the Strategic Alliance Agreement between the parties through October, 2009. This extension will enable the companies to continue work on the development and commercialization of two tests, OVA1(TM) and VASCLIR(TM).
The OVA1 test is intended to identify women with ovarian tumors that are at high risk of being malignant. Data from a 27-site, 511 subject prospective clinical trial were submitted to the FDA in June of this year in a 510(k) premarket notification. Vermillion's 510(k) premarket notification submission is currently pending before the FDA. To date, Vermillion and the FDA have had several substantive discussions regarding the submission. Vermillion is encouraged by the constructive nature of these discussions and by the interactive review process with the FDA. Vermillion believes that it will be able to provide information and data to the FDA that will respond to the FDA's questions during this quarter. Additionally, this week Vermillion presented preliminary data from its OVA1 prospective clinical trial at the International Gynecologic Cancer Society's 12th Biennial Meeting. The oral presentation, "A Biomarker Panel for Distinguishing Between Malignant and Benign Ovarian Tumors" was co-authored by scientists at Vermillion, Dr. Fred Ueland, Associate Professor of Gynecologic Oncology at the University of Kentucky and Principal Investigator of the OVA1 trial, and Dr. Zhen Zhang, Associate Professor of Pathology at Johns Hopkins University School of Medicine.
VASCLIR is a test designed to aid physicians in identifying those patients who are at high risk of developing peripheral artery disease. Vermillion is developing this test in collaboration with Dr. John Cooke at Stanford University. Results from a 540 subject validation study were recently published in the peer-reviewed journal, Vascular Medicine.
"Quest Diagnostics is a pioneer in developing innovative new diagnostic tests and we are very excited to continue this relationship," said Gail S. Page, CEO and President of Vermillion.
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 verify the capability of such tests 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.
Vermillion'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 those patients having a 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 Peripheral Artery Disease (PAD)
PAD, a serious but often asymptomatic disorder affecting some eight to 12 million Americans, is caused by the buildup of fat and cholesterol, or plaque, in the peripheral arteries, disrupting normal blood flow. Left untreated, PAD more than doubles the risk of heart attack and stroke and increases the risk of amputation and death. Provided the disease is identified in a timely manner, there are treatments that can save the lives and limbs of these patients.
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
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 or PAD 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 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 or PAD 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.
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