CHOLESTRAC OTC CHOLESTEROL TEST LAUNCH PLANNED FOR U.S.
This article was originally published in The Tan Sheet
Executive Summary
CHOLESTRAC OTC CHOLESTEROL TEST LAUNCH PLANNED FOR U.S. at mid-year, according to American Home Products subsidiary Whitehall Labs, which has marketing rights to the test. On March 2, CholesTrac became the first over-the-counter cholesterol test to obtain FDA marketing clearance. CholesTrac was developed by its manufacturer, diagnostics firm ChemTrak. Whitehall has not yet announced the consumer price for the cholesterol test, but has been selling the test overseas since 1991 for prices ranging between $ 10-$ 15. Whitehall overseas distribution arrangements 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 essentially the same test 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. Approximately two minutes after a drop of blood is placed in the cassette, plasma is separated from the blood sample. The user then pulls a tab that initiates chemical reactions with the plasma and results in a colorband that can be read much like a thermometer. The user compares the length of the resulting colorband 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 an HHS announcement on the clearance of the OTC test, FDA Commissioner David Kessler underscored 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 added that "this test can help give consumers greater opportunity to monitor their health and take steps to prevent disease." ChemTrak said that it is developing other formats for use with 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, and heart enzyme level monitoring.