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Vermillion Announces Positive Top-Line Data From Intended Use Study For Peripheral Artery Disease (PAD)

AUSTIN, Texas, Oct. 3, 2011 /PRNewswire/ -- Vermillion, Inc. (NASDAQ: VRML), a molecular diagnostics company, today announced positive top-line results from the intended use study for its peripheral artery disease (PAD) blood test, VASCLIR®. The goals of the study were to validate the markers described in earlier publications ( Circulation, 2007 and Vascular Medicine, 2008) and to develop and validate a biomarker panel applicable to the intended use population.

Key takeaways from the study include the following:

  • The individual biomarkers beta 2 Microglobulin (b2m), cystatin C, and hsCRP, each has statistically significant different levels between PAD subjects and non-PAD subjects (p<.001).
  • As in the previous study, these biomarkers also showed correlation to the ankle-brachial index (ABI), each with p<.001.
  • Preliminary assessment of candidate biomarker panels derived in the intended use population demonstrated an odds-ratio of approximately 7.

The intended use study was a prospective, double-blinded multi-center study of approximately 1,000 subjects who met specific inclusion criteria for being at increased risk of having PAD, including smokers and diabetics age 50 or above and elderly age 70 or above. The study was conducted in conjunction with CPC Clinical Research, led by William R. Hiatt, MD, who is currently the Novartis Foundation endowed professor for cardiovascular research in the Department of Medicine, University of Colorado School of Medicine appointed in cardiology and a clinical focus in vascular medicine.

"We are very pleased with the preliminary results of our intended use study. The next steps include optimizing the panel composition as well as additional analyses comparing the panel with the American Heart Association (AHA) cardiovascular risk score. We look forward to publicly sharing the final results in conjunction with their formal presentation at a cardiovascular meeting. The results of this study put us one step closer to developing a simple to use, blood based test to aid physicians in the diagnosis of PAD, a large and growing market," said Gail S. Page, Chief Executive Officer of Vermillion, Inc.

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.  Additional information about Vermillion can be found at www.vermillion.com.

Forward-Looking Statement:

Certain matters discussed in this press release contain 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. Factors that could cause actual results to materially differ include but are not limited to: (1) uncertainty as to Vermillion's ability to protect and promote its proprietary technology; (2) Vermillion's lack of a lengthy track record successfully developing and commercializing diagnostic products; (3) uncertainty as to whether Vermillion will be able to obtain any required regulatory approval of its future diagnostic products; (4) uncertainty of the size of market for its existing diagnostic tests or future 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; (5) uncertainty that Vermillion will successfully license or otherwise successfully partner with third parties to commercialize its future products; (6) uncertainty whether the trading in Vermillion's stock will become significantly less liquid; and (7) 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 this report, 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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