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Vermillion Releases Initial Results from Vasclir Intended Use Study


This story originally ran on Oct. 6

Vermillion this week released top-line data from the intended use study for its peripheral artery disease biomarker test Vasclir.

The results demonstrated that the individual protein markers beta 2 microglobulin, cystatin C, and hsCRP are each expressed at statistically significant levels between PAD subjects and non-PAD subjects, the company said.

The biomarkers also showed correlation with the ankle-brachial index, a measure of the ratio of blood pressure in the lower legs to blood pressure in the arms that is used to detect PAD.

The intended use study was a prospective, doubled-blinded multicenter study of roughly 1,000 subjects at increased risk of PAD, including smokers and diabetics age 50 or above and elderly subjects 70 or above. It was done in conjunction with clinical research organization CPC Clinical Research.

Vasclir is the second test Quest Diagnostics accepted from the company as part of the partners' three-test strategic alliance agreement, and is currently one of Vermillion's primary research focuses.

In a statement, Vermillion CEO Gail Page said that the company's next steps for the test include "optimizing the panel composition as well as additional analyses comparing the panel with the American Heart Association cardiovascular risk score." The company plans to present final results from the study at a future cardiovascular meeting, she added.

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