FDA Rejects PreMD's Skin Cholesterol Test

I had recently written about a promising new skin cholesterol test that would be able to detect heart disease. Designed by PreMD, the POC Skin Cholesterol Test is already being used in other countries to screen asymptomatic and symptomatic patients for heart disease. Currently, this test in only approved in the US for individuals who already have diagnosed heart disease. The company was seeking approval for the skin cholesterol test in individuals with no symptoms of heart disease . PreMD has recently reported that the Food and Drug Administration (FDA) has rejected this use of their skin cholesterol test, stating that it needed more proof with regards to a correlation between heart disease (in the form of carotid artery thickness) and skin cholesterol in people who were asymptomatic for heart disease. The company is currently reviewing the FDA's remarks and plans to address these in the near future.