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Biotech / Medical : IMI:TSE International Medical Innovations Inc. -- Ignore unavailable to you. Want to Upgrade?


To: gg cox who wrote (11)6/24/2002 6:44:39 PM
From: gg cox  Read Replies (1) | Respond to of 66
 
""""A key, however, remains approval from the U.S. Food and Drug Administration, with
response to IMI's application expected within weeks."""

IMI halted today.. they have approval from FDA for Cholesterol 1 2 3 skin test!

Reuters Business Report
US Clears IMI's Skin Cholesterol Test

WASHINGTON (Reuters) - U.S. regulators said on Monday they had approved IMI International Medical Innovations Inc.'s (Toronto:IMI.TO - News) Cholesterol 1,2,3 test, a new laboratory test that measures skin cholesterol in adults with severe coronary artery disease.
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The test can help determine the amount of cholesterol in skin using the palm of the hand, the Food and Drug Administration said in a statement. High cholesterol raises the risk of heart disease.

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

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 three 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.

IMI International Medical Innovations is based in Toronto, Canada.

biz.yahoo.com