New Product: Cholesterol 1,2,3

Non-invasive cholesterol test for risk assessment of heart disease.

WASHINGTON (The FDA) - FDA today cleared a new laboratory test to measure skin cholesterol in adults with clinically significant disease AND anyone suspected to have 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.

The test involves placing a Band-Aid-like applicator pad on the palm of the hand for 3 minutes. A hand-held reader attached to a computer tells how much cholesterol was detected.

The test cannot be used for people with skin diseases on the hand, or on people who have recently applied skin lotions or topical medications, the FDA said.

How Cholesterol 1,2,3 works:

Cholesterol 1,2,3 is a simple, three-minute procedure done on the palm of the hand by a health care professional in a doctors office or pharmacy.
A foam pad with three wells is placed on the palm of the hand, near the base of the last finger. (The wells hold the drops of liquid in place.) A drop is placed in the middle well, and left for one minute. This drop contains digitonin, which binds to cholesterol in the skin. It also contains an enzyme (horseradish peroxidase) linked to the digitonin by a copolymer. After one minute the area is blotted dry; some of the digitonin remains on the palm, bound to any cholesterol in the skin.

A second drop is then added, containing a substrate for the horseradish peroxidase enzyme. The enzyme bound to the skin reacts with the substrate and causes this second drop to turn a shade of blue. After two minutes, a hand-held spectrophotometer is placed over the drop and measures the precise blue colour, which indicates the skin cholesterol value.

It will be available later this year for doctors offices and pharmacies

Source: Food and Drug Administration Talk Paper T-02-27, June 24, 2002.

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