Originally Published IVD Technology July/August 2002
Industry News
Convenience is key to marketing home cholesterol tests
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The Cholesterol 1,2,3 test is the first noninvasive cholesterol test approved by FDA. The test measures skin cholesterol levels to assess a patient’s risk of coronary artery disease. |
IMI received FDA clearance for its Cholesterol 1,2,3 test—the first noninvasive cholesterol test cleared by FDA. The test can be used with traditional risk factors to assess a patient's risk of coronary artery disease. Cholesterol 1,2,3 provides a quantitative assessment of coronary artery disease risk by measuring the amount of cholesterol in the skin. The test will first be marketed to physicians, but the at-home market offers the most potential for the product.
"Skin cholesterol is an entirely new risk factor in assessing a person's cardiovascular health," says Dennis Sprecher, MD, head of preventive cardiology at the Cleveland Clinic Foundation (Cleveland, OH). "It's a whole new tool for patients and doctors in assessing coronary artery disease risk."
A foam pad and three drops of a reagent combination are applied to the palm of the hand and a chemical-based reaction produces a color that is measured with a reader, which provides a quantitative result. "The 1,2,3 technology does not require patients to fast and does not involve the discomfort of a needle," says Tim Currie, director of business development at IMI.
The Lifestream cholesterol monitor measures total blood cholesterol and incorporates the Microsoft Smart Card operating system, which allows consumers to store test results and share them with their healthcare provider.
The professional version of the monitor provides both a total cholesterol reading and multiple health-risk assessments for primary care physicians. Brian Packard, vice president of marketing for Lifestream Technologies, says that the company focuses primarily on distributing its home-based systems, but the physician plays a key role in marketing the technology. "The physician is an important consumer, but is even more valuable as an endorser of the technology," says Packard.
According to the U.S. National Cholesterol Education Program (NCEP), an estimated 101 million Americans have high cholesterol. The NCEP recommends that everyone age 20 and older should have their cholesterol measured at least once every five years. The higher a person's cholesterol level, the more likely the person is to develop heart disease, which is the number one killer of both women and men in the United States.
To date the American Heart Association hasn't taken a position on home-use cholesterol tests, but NCEP mentions self-monitoring in its Adult Treatment Program (ATP) III guidelines.
The guidelines state that physicians should involve patients in their care through self-monitoring. "Involving the patient in their treatment through self-monitoring is another powerful way to improve adherence. In this manner persons can follow firsthand their response to treatment and their progress toward achieving and maintaining treatment goals. They can also observe the consequences of nonadherence."
Packard agrees that frequent testing helps patients stay involved with the condition.
Because high cholesterol levels don't affect the way people feel on a day-to-day basis, he says that it's difficult for people to maintain their therapy.
"The bane of preventive medicine has always been poor compliance; hopefully, by making cholesterol monitors convenient and accessible, we'll increase compliance and awareness for patients with high cholesterol levels," says Packard.
Photo Courtesy International Medical Innovations
Copyright ©2002 IVD Technology
