Vermillion Announces Publication of Data Supporting Its Peripheral Artery Disease Diagnostic Test Program

FREMONT, Calif., Aug. 22 /PRNewswire-FirstCall/ -- Vermillion, Inc. , a molecular diagnostics company, announced the publication of data supporting its peripheral artery disease (PAD) diagnostic program. The results were published in the August, 2008 issue of the peer-reviewed journal, Vascular Medicine. The study was led by John Cooke, MD, PhD, Professor of Medicine at Stanford University and involved researchers at Stanford, Mt. Sinai Medical Center (New York), and Vermillion.

“PAD is a serious disease that often goes undiagnosed and untreated,” said Dr. John Cooke. “A blood test that identifies people at risk for this debilitating condition will improve diagnosis and give these people a better chance of getting the life- and limb-saving therapy they need. Our study indicates that this biomarker panel could assist physicians in identifying those individuals at highest risk of having PAD.”

The study comprised 540 individuals: 197 individuals with both coronary artery disease and peripheral arterial disease (CAD + PAD); 81 with CAD only; and 262 with no hemodynamically significant disease (NHSD) of the coronary or peripheral arteries. Blood plasma was analyzed for a series of candidate biomarkers, and a final biomarker panel comprising Beta-2M, cystatin C, hsCRP, and glucose had an increased association with PAD status (odds ratio = 7.3).

Vermillion has entered into an exclusive license agreement with Stanford to develop and commercialize the PAD biomarker panel.

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. There are treatments that can save the lives and limbs of these patients, once the disease is recognized.

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 is no guarantee of a correlation between identified biomarkers and PAD diagnosis. Even if such a correlation is identified, commercialization of a PAD diagnostic test is uncertain. Factors that could cause actual results to differ materially 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.

CONTACT: Sue Carruthers of Vermillion, Inc., +1-510-226-2811

Web site: http://www.vermillion.com/

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