FDA Approves Cholesterol Skin Test
The Food and
Drug Administration on approved a new test that will allow cholesterol
levels to be measured from the skin on the palms of adults with coronary
artery disease rather than from blood samples, as current cholesterol tests
require.
The test, called
Cholesterol 1, 2, 3, has been approved only for people with severe coronary
artery disease and those who have had a heart attack.
"The Cholesterol
1,2,3 test was not shown to be useful in identifying people with less severe
coronary artery disease (and) is not intended to be used as a screening
tool to determine risk for coronary artery disease in the general population,"
the FDA said in a statement.
The agency
noted the test "is intended to be used along with -- not as a substitute
for -- the standard blood tests."
"The test represents
new information for the patient to use in assessing coronary artery disease
risk," Andrew Weir, spokesman for the test manufacturer, International
Medical Innovations, Inc., of Toronto, Canada, told United Press International.
"It's done painlessly ... with no need to fast prior to the test" as is
required by blood cholesterol tests, he said.
Although the
test is not approved for the general population, Weir said, "The vision
is that this will someday become a screening test for everyone to use."
International
Medical has "a number of major studies underway right now that are looking
at normal populations" and the company anticipates getting an expanded
approval within two years, he said.
The company
currently is completing discussions with a marketing and distributing partner
and plans to make the test available in doctor's offices and laboratories
in the next several months.
The test involves
placing a band-aid like applicator pad on the palm of the hand and applying
a chemical solution. After three minutes, a handheld reader determines
the cholesterol level based on the hue of the color blue the pad registers.
Cholesterol
level is displayed on a computer screen attached to the handheld reader.
In clinical
trials involving more than 600 patients known to have blockage of their
coronary arteries, the test, combined with a standard blood cholesterol
test, correctly identified those with the most severe blockage.
People with
skin diseases cannot use the test. Skin lotions and topical medications
also will interfere with its accuracy.
Most of the
people involved in the clinical trials were Caucasian and between the ages
of 40 to 82, so the test may not offer accurate reading for different races
and ages, the FDA said.
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