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  US Clears Skin Test for Cholesterol

WASHINGTON (Reuters) - US regulators said on Monday they had approved the first skin test for cholesterol to help doctors identify patients with severe coronary artery disease.

The Cholesterol 1,2,3 test, made by IMI International Medical Innovations Inc. of Toronto, Canada, checks the amount of cholesterol in skin using the palm of the hand, the Food and Drug Administration (FDA) said in a statement.

The test is not meant to replace standard blood tests to measure cholesterol, but it can be used with them to help identify patients with severe heart disease, the FDA said.

"It provides additional information above what traditional risk factors provide" to physicians as they try to determine how to treat patients, said Michael Evelegh, IMI's executive vice president for clinical and regulatory affairs.

The higher the skin cholesterol, the more likely it is that a patient has cardiovascular disease, Evelegh said.

In a study of 649 patients with known coronary artery blockages, the skin test, combined with a blood test, helped identify patients who had the most severe blockages, the FDA said. The test did not help identify people with less severe coronary artery disease, the agency noted.

According to the FDA, the test provides "4 percent to 15 percent more information about the risk of severe coronary artery disease beyond that already available with blood cholesterol and other risk factors."

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.

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