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| T02-27 | Media Inquiries: 301-827-6242 |
| June 24, 2002 | Consumer Inquiries: 888-INFO-FDA |
FDA today 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.
For the palm cholesterol test, a band-aid-like applicator pad was placed on the palm of the hand. Drops of reagent solution were added to the pad, which remained on the palm for three minutes. A handheld reader attached to a computer was then used to read the amount of blue color in the pad. The results were displayed on the computer screen. The deeper the blue, the more cholesterol was detected.
The Cholesterol 1,2,3 test was not shown to be useful in identifying people with less severe coronary artery disease. Therefore, it is not intended to be used as a screening tool to determine risk for coronary artery disease in the general population.
The test cannot be used on people with skin diseases on the hand or on those who recently applied skin lotions or topical medications. Also, the test results may be race and age dependent. Most of those studied were Caucasian, ages 40 to 82.
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