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Home cholesterol tests seek FDA approval
According to Christopher Maus, chairman and CEO of Lifestream (Fort Collins, CO) more than 97 million people in the United States have elevated cholesterol levels. These people may soon be able to determine their cholesterol level and monitor their progress with Lifestream's home cholesterol monitor.
Lifestream is conducting clinical trials with the monitor in preparation for a 510(k) submission to FDA. "We anticipate filing with FDA by the end of November," says Jack Connolly, Lifestream's vice president for product development.
The clinical trial protocol was a result of FDA review and suggestions that focused on the need for consumer cholesterol screening and monitoring. The trials are being conducted in Boston, San Francisco, and Seattle. According to Connolly, the protocol is designed to "capture three separate user types: those that don't know their cholesterol level and want to know what it is, those that do know and want to monitor it, and those that are under a physician's care and must know what their cholesterol level is."
The company's Consumer Cholesterol Monitor is an instrument-based, quantitative consumer-use system. It is a handheld device that identifies and displays on a meter the total cholesterol from one drop of blood in approximately three minutes. Test results can also be stored on the company's smart card and used with the meter to display previous results and deliver an average of the last six readings.
Future filings with FDA may include use of the company's monitor in conjunction with a subscription-based, closed Internet Web site, allowing healthcare professionals to transmit test results and personal health data from the instrument, says Connolly.
While Lifestream continues to work on its instrumented approach to home-use cholesterol monitoring, the market is also beginning to attract competitors. Technical Chemicals and Products Inc. (TCPI; Pompano Beach, FL) recently filed a 510(k) application to FDA for its HealthCheck total cholesterol home screening test. The company also announced that it is conducting clinical trials for its HDL cholesterol home screening test.
Both of TCPI's tests are designed for home use. Test results from the HealthCheck test indicate that the user falls into one of three medical risk groups according to their total cholesterol level: less than 200 mg/dl, (low risk for heart disease); 200–239 mg/dl, (borderline-high risk for heart disease); and 240 or higher mg/dl (increased risk for heart disease). The risk levels adopted by the company match those determined by the National Cholesterol Education Program.
"Our total and HDL cholesterol tests use the company's proprietary and patented membrane-based technology," says Jeffrey Bolts, PhD, TCPI's director of regulatory affairs. "The test strip changes color in proportion to the amount of total or HDL cholesterol present. The color change allows the user to visually compare the test strip to a standardized color chart, and to determine the appropriate total or HDL medical risk group."—Gabe Spera
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