digitonin and Coronary-Artery-Disease

Cholesterol 1,2,3 9 (TM) is being promoted as a non-invasive way to measure cholesterol that has accumulated in a person's skin. The test received a medical device licence from Health Canada in January 2001. It was approved by the U.S. Food and Drug Administration (FDA) in June 2002. This test is not intended to be used as a screening tool for coronary artery disease in the general population. Evidence from non-randomized, non-blinded clinical trials suggests a correlation between higher skin cholesterol levels and the presence of severe coronary arterial lesions. At this point, technical improvements and more robust evidence are required to determine the significance of this technology in clinical practice.

Topics: Canada; Cholesterol; Clinical Trials as Topic; Coronary Artery Disease; Cost-Benefit Analysis; Device Approval; Digitonin; Horseradish Peroxidase; Humans; Indicators and Reagents; Skin; Technology Assessment, Biomedical; United States; United States Food and Drug Administration