Vermillion Biomarker Panel Potential Aid In The Diagnosis Of Peripheral Artery Disease

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials;  Conferences
Article Date: 09 Apr 2008 - 0:00 PDT

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Vermillion, Inc. (Nasdaq: VRML), a molecular diagnostics company, presented data from a study providing further confirmation that the Company's multi-protein biomarker panel may aid in the diagnosis of peripheral artery disease (PAD). The research suggests that such a panel may be useful in alerting physicians to the possibility of PAD in patients who might otherwise be undiagnosed. Results of the study were presented as a poster at the American College of Cardiology 57th Annual Scientific Session.

Working in collaboration with researchers at Stanford University, Vermillion intends to develop a blood test for the diagnosis of PAD. In March, the Company entered into an exclusive license agreement with the University to develop and commercialize a biomarker panel used to assess the risk of the disease, which is estimated to affect up to 12 million Americans and can result in severe complications, including amputation, heart attack, stroke and even death.

"Few studies have explored combinations of protein markers to create a distinct biomarker panel score to stratify individuals according to their risk of having PAD. However, our study successfully accomplishes this by discovering a multi-marker panel that could significantly aid in identifying such patients," said Eric T. Fung, M.D., Ph.D., Chief Scientific Officer of Vermillion. "We are pleased with these findings and are developing a clinical trial protocol to generate data for support of a submission to the U.S. Food and Drug Administration (FDA)."

The study was conducted to develop an index score based on a combination of proposed biomarkers for PAD, including two based on proteomic discovery. A total of 540 patients were analyzed in the study. These patients were randomly selected from the ongoing GenePAD trial, which comprises individuals undergoing coronary angiography at Stanford University or Mount Sinai Medical Centers. The company expects to publish results from this study in a peer-reviewed medical journal.

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 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 PAD 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 PAD diagnostic products; (4) uncertainty as to whether Vermillion will be able to obtain any required regulatory approval of its PAD diagnostic products; (5) uncertainty of market acceptance of its PAD 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.

Vermillion, Inc.
http://www.vermillion.com