Vermillion has reported positive results from the intended use study of its peripheral artery disease (PAD) blood test - Vasclir.
The goals of the study were to validate the markers and to develop and validate a biomarker panel applicable to the intended use population.
The double-blinded, multi-center, prospective study was designed to study 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 showed that the individual biomarkers beta 2 Microglobulin (b2m), cystatin C, and hsCRP, each has significant different levels between PAD subjects and non-PAD subjects (p<.001).
Preliminary assessment of candidate biomarker panels derived in the intended use population demonstrated an odds-ratio of approximately 7.
Vermillion CEO Gail Page said the results of this study put them one step closer to develop a simple to use, blood based test to aid physicians in the diagnosis of PAD.