Predictive medicine company IMI International Medical Innovations Inc has initiated its first clinical study involving consumer products for risk assessment of coronary artery disease through skin cholesterol. A professional point-of-care skin cholesterol test system - IMI's Cholesterol 1,2,3 - is cleared for sale in the U.S., Europe and Canada, making it the first non-invasive cholesterol test system in the world.

In the trial IMI is evaluating two different products that were developed with input from the company's Canadian marketing partner, McNeil Consumer Healthcare. Both tests feature a simplified test procedure suitable for the consumer market. One test design involves placing the fingertip on a test strip that changes color to indicate the person's skin cholesterol value. In the second design an adhesive device is placed on the palm, then sent to a centralized location such as a laboratory for testing. McNeil will market the tests in Canada once they are cleared for sale.

The clinical trial is being led by the Trillium Health Centre in Toronto, and will include 100 subjects - 50 high-risk subjects and 50 normal-risk subjects. The trial is expected to be completed by the end of this year.

By measuring cholesterol on the surface of the skin, Cholesterol 1,2,3 has been shown in clinical trials to provide new information about coronary artery disease risk that is independent of traditional risk factors such as blood cholesterol. Studies have shown a relationship between skin cholesterol and history of heart attacks, and have demonstrated the incremental value of using Cholesterol 1,2,3 in addition to traditional risk factors in assessing a person's risk of coronary artery disease.