Cholesterol News:

FDA Approves New Cholesterol Test for Adults With Severe Coronary Artery Disease

The U.S. Food and Drug Administration has approved a new laboratory test to measure cholesterol in adults with severe coronary artery disease.

The test, called Cholesterol 1,2,3, can help measure the amount of cholesterol in the skin using the palm of the hand. Current cholesterol tests require a blood sample.

Skin contains about 11 percent of all body cholesterol, by weight. When a patient has severe coronary artery disease, the numeric values obtained by the Cholesterol 1,2,3 test increase.

The test consists of an applicator pad that is placed on the palm of the hand. A few drops of a special solution are placed on the pad, which remains on the palm for three minutes. The pad turns a different shade of blue, depending upon the amount of skin cholesterol found. A handheld reader attached to a computer reads the results which are displayed on a computer screen.

The test is designed for patients who are suspected of having severe coronary artery disease (50 percent closure of two or more arteries) and patients with a history of heart attack. The test is intended to be used along with -- not as a substitute for -- the standard cholesterol blood test along with an evaluation of other risk factors.

Research shows that Cholesterol 1,2,3, made by International Medical Innovations Inc. of Toronto, Canada, provides 4 to 15 percent more information about risk of severe coronary artery disease beyond what is already available with blood cholesterol and other risk factors.

The Cholesterol 1,2,3 test is not intended to be used as a screening tool to determine a patient's risk for coronary artery disease, as it has not been shown useful in identifying patients with less severe coronary artery disease. The test cannot be used on patients with skin diseases on the hand or those who have recently used lotions or topical medications.

Source: Medical Week staff, week of July 7, 2002