PreMD seeks to boost US market potential for skin cholesterol test:
This article was originally published in Clinica
Executive Summary
PreMD has filed a 510(k) marketing application with the US FDA to expanded the indications for its point-of-care (POC) skin cholesterol test Prevu(x), to include it use in assessing cardiovascular disease risk in individuals without known or suspected disease. "An expanded claim could dramatically increase the market potential of Prevu(x) POC," said Brent Norton, the Toronto, Canada firm's president and CEO. It would make the product "the first cost-effective, noninvasive test on the market to help assess carotid wall thickness and the presence of carotid plaques in patients without known coronary artery disease, cerebrovascular disease or peripheral artery disease", claimed the company. Carotid wall thickness and carotid plaques are established markers for future heart attacks and strokes. "Our discussions with potential marketing partners are advancing," said Dr Norton.