Palm Test For Skin Cholesterol
The FDA cleared a new laboratory test to measure skin cholesterol in adults with severe coronary artery disease. The test can help determine the amount of cholesterol in skin using the palm of the hand. Other cholesterol tests currently used by laboratories measure cholesterol from blood samples.
The test, called Cholesterol 1,2,3, is made by International Medical Innovations Inc. of Toronto, Canada.
It is for testing people suspected of having severe coronary artery disease (defined as 50 percent closure of two or more arteries) and those with a history of heart attack. Cholesterol 1,2,3 is intended to be used along with--not as a substitute for--the standard blood tests. Nor can it substitute for an evaluation of other risk factors used to identify coronary artery disease.
FDA's decision to clear the test for marketing was based on a review of the firm's clinical studies that showed, in patients with severe disease or previous heart attack, it could provide 4% to 15% more information about risk of severe coronary artery disease beyond that already available with blood cholesterol and other risk factors.
Skin contains approximately 11 percent by weight of all body cholesterol. When severe coronary artery disease is present, the numeric values obtained with the skin cholesterol test increases.
In a study with 649 patients who each had a known degree of coronary artery blockages, the skin cholesterol test, combined with a blood cholesterol test, helped identify patients who had the most severe artery blockages.
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