Vermillion Announces Positive Top-Line Data from Intended Use Study for PAD
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Vermillion, Inc. has 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.
