PREVU* Skin Cholesterol Test non-invasively and painlessly measures skin tissue cholesterol, or skin cholesterol. As a new risk factor for heart disease, skin cholesterol provides valuable additional information to traditional CAD risk assessment. Skin contains over 11% of the body’s cholesterol and ages in parallel with vascular connective tissue. As blood vessel walls accumulate cholesterol, so do the skin tissues. A high skin cholesterol level is a reliable predictor of higher cholesterol accumulation in the arteries and, accordingly, risk of heart disease.
Currently marketed as PREVU*, the Skin Cholesterol Test is planned to be marketed and distributed by AstraZeneca Pharmaceuticals in the U.S. in 2008. |
What is coronary artery disease (CAD)?
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| Coronary artery disease, or heart disease, is a leading cause of death worldwide. Heart disease occurs when fat and cholesterol gradually accumulate in the coronary arteries, forming a plaque that narrows the artery and reduces blood flow to the heart. Undetected or untreated, this build-up can block the artery and cause a heart attack. A heart attack, also known as a myocardial infarction (MI), causes a part of the heart muscle to die, which weakens the heart’s ability to pump blood. Worldwide, about 7.3 million people die from heart attacks every year. |
What are the risk factors for CAD?
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| A major risk factor for CAD is high blood cholesterol. It is estimated that clinical laboratories in the U.S. now perform approximately 250 million cholesterol tests per year and another 290 million clinical laboratory tests are performed in the rest of the world.
However, blood cholesterol tests may be highly variable in results over a series of days, relatively expensive to perform and require a fasting blood sample from the patient.
In fact, several studies suggest that about half of all heart attack patients actually have blood cholesterol levels within what is considered a normal, healthy range. So while blood cholesterol remains an important risk factor for heart disease, it is widely accepted that several risk factors for CAD must be considered to provide an accurate picture of absolute risk of disease.
Absolute cardiovascular disease risk is determined by a combination of all cardiovascular risk factors present. Other traditional and emerging risk factors include:
- Gender;
- Increasing age and heredity;
- Tobacco smoking;
- High blood pressure;
- Physical inactivity, diet and obesity;
- Diabetes mellitus;
- C-reactive protein (CRP);
- Homocysteine;
- Carotid intima-media (CIMT) thickness; and
- Coronary calcium, among others.
Many of these factors are costly to measure or assess, are resource intensive and inappropriate for a primary care setting, or require invasive procedures.
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About PREVU* Skin Cholesterol Test
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PREVU* Point of Care (POC) Skin Cholesterol Test is a non-invasive, painless and cost-effective tool to measure skin cholesterol that does not require any patient preparation or dietary changes.
This simple test is conducted by placing a drop of digitonin, which binds selectively to the cholesterol in the skin, on the palm of the hand. This liquid also contains an enzyme (horseradish peroxidase) linked to the digitonin by a copolymer. After a one-minute incubation period, the area is blotted dry to remove any unbound digitonin solution. A second drop of liquid is then added, containing a substrate for the horseradish peroxidase enzyme. When combined, a blue color change occurs in direct proportion to the amount of digitonin that is bound to skin cholesterol. After two minutes, a hand-held spectrophotometer (color reader) is placed over the drop to measure the precise blue color, which indicates the skin cholesterol value.
PreMD has leveraged this technology into two additional formats:
- PREVU* LT Skin Cholesterol Test, a lab-processed format which has been cleared for sale in Canada and Europe; and
- PREVU* PT Skin Cholesterol Test, a consumer, or home use test, format, currently in development.
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Regulatory Approvals
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In Canada and Europe, PREVU* POC and PREVU* LT are cleared for use as part of risk assessment for CAD.
In the U.S., PREVU* POC is cleared for use as part of risk assessment for CAD in persons with a history of heart attack and/or in persons suspected of having clinically significant coronary artery disease (>50% stenosis, or blockage, in more than one vessel, as diagnosed by angiography). Skin cholesterol test results, when considered in conjunction with clinical evaluation, blood cholesterol and other risk factors identified for coronary artery disease, will aid the physician in focusing diagnostic and patient management options. PREVU* POC is CLIA-exempt.
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Marketing & Distribution
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On July 13, 2007, PreMD announced a licensing agreement with AstraZeneca Pharmaceuticals for the U.S. marketing and distribution of the skin cholesterol test, currently marketed as PREVU*. Under the terms of the agreement, AstraZeneca will have the exclusive right to market and distribute the skin test into the healthcare community, including physician offices, hospitals, retail chains and other institutions in the U.S. PreMD retains exclusive rights to promote PREVU* products to the life-insurance industry and other future applications of the technology under the PREVU* brand. AstraZeneca is planning to begin marketing and distributing the product line to healthcare professionals in the U.S. in 2008.
For information about Marketing and Distribution, please contact PreMD's Corporate Development team. |
