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CHOLESTRAC OTC CHOLESTEROL TEST U.S. LAUNCH PLANNED FOR MID-YEAR

This article was originally published in The Gray Sheet

Executive Summary

CHOLESTRAC OTC CHOLESTEROL TEST U.S. LAUNCH PLANNED FOR MID-YEAR, according to American Home Product's Whitehall Laboratories, which has marketing rights to the ChemTrak test. On March 2, CholesTrac became the first over-the-counter cholesterol test to obtain FDA marketing clearance. Whitehall has not yet announced the consumer price for the cholesterol test, but it has been selling the product overseas since October 1991 for prices ranging between $10 and $15. Whitehall arrangements for overseas distribution include agreements with Boots the Chemists in England and with A. Menarini in Italy; the device also is being sold in Singapore, Korea and the Middle East. Whitehall's existing U.S. line of OTC diagnostics includes the Clearblue Easy pregnancy test and the Clearplan Easy ovulation predictor kit. CholesTrac is the same device as the AccuMeter, which ChemTrak has been marketing for professional use since May 1991. Provided as a palm-sized disposable cassette test, Cholestrac measures total cholesterol levels within 15 minutes ("The Gray Sheet" Mar. 25, 1991, p. 21). A drop of whole blood is placed in the device, which in approximately two minutes separates plasma from the blood. The user then pulls a tab that initiates chemical reactions with the plasma and results in a color band that can be read much like a thermometer. The user compares the length of the resulting color band to a cholesterol level conversion chart included with the OTC device. Several published studies have indicated that ChemTrak's tests are 96%-99% as accurate as the Abell-Kendall test, the standard total cholesterol testing method used by the Centers for Disease Control and Prevention. In a Health and Human Services press release announcing clearance of the OTC test, FDA Commissioner David Kessler comments that "accuracy is crucial. It is also important, as the study [submitted by ChemTrak] showed, that participants were able to read and understand the instructions and perform the test without assistance." HHS Secretary Donna Shalala adds: "This test can help give consumers greater opportunity to monitor their health and take steps to prevent disease." ChemTrak says that it is developing other devices using the patented cassette technology, including tests to measure high- and low-density lipoproteins. ChemTrak believes the technology also has potential application for AIDS and hepatitis testing, as well as heart enzyme level monitoring.
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