On 3 October, Vermillion, a molecular diagnostics company, announced positive top-line results from the intended use study for its peripheral artery disease 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.
Vasclir is a novel blood test to stratify an individual’s risk to develop peripheral artery disease. It simultaneously evaluates various biomarkers for this condition and creates and index score. Previous studies have shown that patients with a high index score are seven times more likely to have peripheral artery disease than patients with a low index score. Vasclir has been developed in conjunction with researchers at Stanford University.
The intended use study was a prospective, double-blinded multicentre study of approximately 1,000 subjects who met specific inclusion criteria for being at increased risk of having peripheral artery disease, 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 who is currently the Novartis Foundation endowed professor for cardiovascular research in the Department of Medicine, University of Colorado School of Medicine, USA, appointed in cardiology and a clinical focus in vascular medicine.
- The individual biomarkers beta 2 Microglobulin (b2m), cystatin C, and hsCRP, each has statistically significant different levels between peripheral artery disease subjects and non-peripheral artery disease 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.
“We are very pleased with the preliminary results of our intended use study. The next steps include optimising 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 peripheral artery disease, a large and growing market,” said Gail S Page, Vermillion’s CEO.