Vermillion, a molecular diagnostics company, has reported positive results from the intended use study for its peripheral artery disease (PAD) blood test, Vasclir.
The prospective double-blinded multicentre study enrolled about 1,000 subjects who met specific inclusion criteria for being at increased risk of having PAD, including smokers and diabetics aged 50 or above and the elderly aged 70 or above.
The aim of the study is to develop and validate a biomarker panel applicable to the intended use population.
The individual biomarkers beta 2 microglobulin (b2m), cystatin C and hsCRP has significantly different levels between PAD subjects and non-PAD subjects.
In the previous study, these biomarkers showed correlation to the ankle-brachial index (ABI).