Skin Cholesterol Linked To Cardiovascular Disease Risk In Asymptomatic Individuals

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PreMD's novel non-invasive skin cholesterol test has demonstrated the ability to detect risk of cardiovascular disease in asymptomatic subjects, according to new data being presented this morning at the Annual Scientific Sessions of the American Heart Association in Orlando, Florida.

This study marks the largest clinical trial to date to evaluate levels of skin cholesterol in asymptomatic individuals. Entitled -"Increased Skin Cholesterol Identifies Individuals at Increased Cardiovascular Risk: The Predictor of Advanced Subclinical Atherosclerosis (PASA) Study," the study supports the usefulness of non-invasive skin cholesterol measurements for cardiovascular disease risk assessment.

Results of the PASA Study showed that skin cholesterol content, measured by PreMD's skin cholesterol test, was associated with carotid intima-media thickness (CIMT) and the presence of carotid plaque. This association was observed in subjects across all ranges of cardiovascular risk, particularly in those at low and intermediate risk, based on traditional cardiovascular risk factors. CIMT and carotid plaque are both well-established markers for risk of future heart attack and stroke.

"Because skin cholesterol content can non-invasively identify individuals with advanced subclinical atherosclerosis, it may become an important office-based tool for cardiovascular risk prediction," said lead investigator, James H. Stein, MD, Associate Professor of Medicine, Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health.

"These study results show that even low and intermediate risk subjects with elevated skin cholesterol are at increased risk of cardiovascular disease," said Dr. Brent Norton, president and chief executive officer of PreMD. "These very important data supports the utility of our skin cholesterol test as part of cardiovascular risk assessment for asymptomatic subjects. We anticipate that these findings will help us obtain broader clearance with the U.S. Food and Drug Administration (FDA) on our skin cholesterol test."

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"Refining cardiovascular risk assessment remains a challenging task, especially because most advances are based on expensive imaging technologies or sophisticated blood testing," said G. B. John Mancini, MD, FRCPC, FACC, Professor of Medicine, Division of Cardiology, University of British Columbia. "This study shows that the skin cholesterol measurement is independently associated with subclinical atherosclerosis. This is extremely exciting news because the methodology is simple, completely non-invasive and practical for widespread use."

PreMD's skin cholesterol test non-invasively measures the amount of cholesterol that has accumulated in the skin tissues. There is no fasting or other patient preparation required for the test. Clinical studies have demonstrated an association between cholesterol accumulation on artery walls and its accumulation in skin. High levels of skin cholesterol are correlated with higher incidence of coronary artery disease (CAD). PreMD's skin cholesterol test is cleared for sale in Canada and Europe but not yet cleared for use in asymptomatic subjects in the U.S., which is currently pending review by the FDA. On July 16, 2007, the company signed an agreement with AstraZeneca Pharmaceuticals LP for the marketing and distribution of the skin cholesterol test in the United States.

Results of the PASA Study

The study, conducted at six sites in North America (University of Wisconsin School of Medicine and Public Health; University of Pennsylvania School of Medicine; University of Chicago Pritzker School of Medicine; University of Minnesota School of Public Health and Minneapolis Heart Institute Foundation; John Hopkins University School of Medicine; and Radiant Research) included 565 asymptomatic individuals. Patients underwent B-mode ultrasonography of the carotid arteries to measure CIMT and carotid plaque, and had skin cholesterol content measured using PreMD's skin cholesterol test. Skin cholesterol was associated with increased risk of having increased CIMT and the presence of carotid plaque, two markers of subclinical atherosclerosis. The relationship between skin cholesterol and these markers of subclinical atherosclerosis was observed across all levels of cardiovascular disease risk and was strongest in subjects at low and intermediate risk based on traditional risk factors. These findings support the potential usefulness of non-invasive skin cholesterol measurements as part of cardiovascular disease risk assessment.

By PreMD Inc.

This page is updated on May 11, 2013.

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