Printer Friendly

CHOLESTEROL HOME TEST KIT CLEARED

 WASHINGTON, March 2 /PRNewswire/ -- The Food and Drug Administration today announced that it has cleared for marketing the first cholesterol test available for home use by consumers without a prescription.
 Previously, cholesterol tests, which are used to help determine the risk of heart disease, were available only for use by medical professionals.
 The test -- the Accumeter Cholesterol Self-Test, made by Chem Trak Inc. of Sunnyvale, Calif. -- comes in a kit and allows the user to find the level of cholesterol in the blood in about 15 minutes.
 "This test can help give consumers greater opportunity to monitor their health and take steps to prevent disease," said Health and Human Services Secretary Donna E. Shalala. "Making it more convenient to check on cholesterol can help ensure that people are aware of the level so they can see a doctor before serious problems develop."
 High cholesterol is only one factor that leads to heart disease. Others include high blood pressure, smoking, obesity and family history of heart disease before age 55. An estimated 17.6 million Americans have heart disease, which claims some 734,000 lives in the United States annually.
 The agency's decision to allow the test to be sold over-the- counter is based on results of a multi-center clinical trial involving nearly 500 adults. The firm's study showed the test to be accurate as cholesterol tests used by doctors and medical laboratories.
 "Accuracy is crucial," said David A. Kessler, M.D., commissioner of Food and Drugs. "It is also important, as the study showed, that participants were able to read and understand the instructions and perform the test without assistance," he noted.
 To perform the test, the user pricks his finger, squeezes blood into a cassette that contains a test strip and then waits 10 to 15 minutes for results. The strip changes color as the cholesterol rises on it. When the time is up, the user compares the height of color shown on the cassette with an accompanying conversion chart to get the cholesterol reading.
 The test measures total cholesterol. It does not measure individual components, such as LDL or HDL cholesterol. A reading of less than 200 is desirable; 200 to 239 is borderline high; and 240 or above is high, meaning the user may be at a greater risk for heart disease. People whose cholesterol is borderline or high should see a doctor.
 The National Institutes of Health's National Cholesterol Education Program recommends that people with a reading in the desirable range have their cholesterol checked once every five years, and that those whose cholesterol is borderline or high follow the recommendation of their doctor for frequency of testing.
 The home test should not be used by hemophiliacs or by people who take medicine to thin blood because of the possibility of excessive bleeding from the finger prick. Those individuals should have their cholesterol checked by their doctors.
 The package labeling for the test includes detailed instructions for proper use and a discussion of the test's limits. It also includes information on cholesterol, heart disease, diet and exercise and lists a toll-free number consumers can call for additional information. The number is 800-927-7776.
 Other home tests approved by FDA include tests for ovulation, pregnancy, blood glucose, hidden fecal blood, blood pressure and urinary tract infections.
 FDA and NIH are among the eight Public Health Service agencies within the Department of Health and Human Services.
 -0- 3/2/93
 /NOTE: Attention TV broadcasters: Please use open caption for the hearing impaired./
 /CONTACT: Sharon Snider of the Food and Drug Administration, 301-443-3285 or, after hours, 301-622-0977/


CO: Food and Drug Administration; Chem Trak Inc. ST: District of Columbia IN: MTC SU:

DC -- DC028 -- 1991 03/02/93 13:19 EST
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Mar 2, 1993
Words:621
Previous Article:CITY REPORTS HIRES FOOD WRITER
Next Article:COAL STRIKE ENDS
Topics:


Related Articles
BIOPOOL TEST KIT POINTS TO t-PA AS INDICATOR FOR HEART ATTACK RISK; HARVARD STUDY PUBLISHED IN LANCET
JOHNSON & JOHNSON DIVISION INTRODUCES HOME CHOLESTEROL DOUBLE-TEST KIT
CHEMTRAK FILES FOR FDA CLEARANCE OF H. PYLORI TEST
CHEMTRAK COMPLETES $5.0 MILLION FINANCING
FDA APPROVES FIRST HOME COLLECTION HIV TEST
CHEMTRAK ANNOUNCES JAPANESE LICENSING DEAL FOR TECHNOLOGY BREAK THROUGH IN ASTHMA PATIENT TESTING
ChemTrak Reports Results for 1996 Fourth Quarter and Year
Walgreens Places Initial Order For TCPI'S HealthCheck Diagnostic Products
Cholestech Corporation Urges Consumers to Get Tested During Cholesterol Awareness Month.
Cholestech Corporation Launches New Dermatology Kit for In-office Cholesterol, Liver and Pregnancy Screening.

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters