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.
Reference
Source 89
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