PreMD trial of Prevu(x) to study relationship between skin tissue cholesterol and heart attack risk

By E. Janene Geiss

Philadelphia, Nov. 3 - PreMD Inc. said Thursday it was beginning a 600-person study to further examine the relationship between skin tissue cholesterol and carotid intima media thickness, which is an established predictor of heart attack and stroke.

The study, Predictor of Advanced Subclinical Atherosclerosis (PASA), is expected to provide data to support broader regulatory clearance for Prevu(x) Point of Care (POC) Skin Sterol Test as a tool to identify asymptomatic patients at risk of a primary event, such as heart attack, according to a company news release.

In the study of 600 asymptomatic patients between 40 and 80 years old, skin sterol, an independent risk factor for coronary artery disease, will be measured by Prevu(x) POC as well as Prevu(x) LT Skin Sterol Test, a lab-processed format of the technology. Carotid intima media thickness is a non-invasive technique that uses ultrasound to scan the carotid arteries for evidence of atherosclerosis and is a validated method for detecting patients with atherosclerosis and predicting future events such as heart attack and stroke, officials said.

"Previous studies have shown that skin sterol is elevated in people who have had a heart attack, and that it is associated with increased CIMT [carotid intima media thickness] in patients with no symptoms of disease," Dr. Brent Norton, president and chief executive officer, said in the release.

"PASA has been designed to generate the data we need to expand Prevu(x) POC's claims for use, which would create exciting new opportunities for the technology and position our test as the only cost-effective tool to predict who is going to have a heart attack, something that a blood cholesterol test cannot do," Norton said.

Prevu(x) tests the amount of cholesterol build-up in the coronary arteries. It does not require the drawing of blood or fasting and takes minutes to perform, officials said.

"There is considerable interest in non-invasive, simple and rapidly administered tests to better assess which patients are at increased risk. We believe that by measuring the cholesterol deposited in the skin, Prevu(x) may actually help a physician and patient predict the future risk of having a heart attack or stroke," Dr. James Stein, a cardiologist at the University of Wisconsin Medical School and principal investigator of the study, said in the release.

Toronto-based PreMD is focused on developing rapid, non-invasive tests for early detection of life-threatening diseases.

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