by Archana Subramaniam by CNB
Roanoke Times Copyright (c) 1995, Landmark Communications, Inc. DATE: WEDNESDAY, March 3, 1993 TAG: 9303030205 SECTION: NATIONAL/INTERNATIONAL PAGE: A1 EDITION: METRO SOURCE: Associated Press DATELINE: WASHINGTON LENGTH: Short
CHOLESTEROL HOME TEST KITS COMING
A home-use kit that enables people to measure their cholesterol was approved Tuesday by the Food and Drug Administration.The Accumeter Cholesterol Self-Test, made by ChemTrak Inc. of Sunnyvale, Calif., gives a total cholesterol reading in 15 minutes.
The kit, to be sold over the counter, was judged by the FDA from a clinical trial on nearly 500 adults to be as accurate as similar cholesterol screening tests used by doctors and medical laboratories.
The study "showed that participants were able to read and understand the instructions and perform the test without assistance," said FDA Commissioner David Kessler.
Cholesterol can be a predictor of heart disease, and government guidelines advise people with normal cholesterol levels to have it checked every five years.
Jerry Gin, executive vice president of ChemTrak, said the test kit is expected to sell for $12 to $15 when it appears in drugstores within a few months.
It does not measure a person's LDL or HDL cholesterol, triglycerides or other fatty acids. It tells if total cholesterol is under 200, the desirable range, or 240 and above, which indicates greater risk for heart disease.