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Cholestech is Ready to Respond to New NIH Guidelines for Cholesterol Management With Its CLIA Waived, Easy-to-Use Testing System and Service.


Business Editors, Health/Medical Writers

HAYWARD, Calif.--(BW HealthWire)--May 17, 2001

The Cholestech L-D-X(R) System Identifies At-Risk Individuals and

Provides Therapeutic Monitoring

Cholestech Corporation (Nasdaq:CTEC CTEC Course and Teacher Evaluation Council (Northwestern University, Office of the Register)
CTEC Certified Technical Education Center
CTEC Certified Technical Education Center (Microsoft) 
), which has shipped more than 13 million tests over the past 4 fiscal years, is ready to respond to Tuesday's announcement by the National Institutes of Health (NIH "Not invented here." See digispeak.

NIH - The United States National Institutes of Health.
) of aggressive new guidelines to address the national effort to reduce heart disease among Americans. The new guidelines are expected to substantially expand the number of Americans being treated for high cholesterol, including raising the number on dietary treatment from about 52 million to about 65 million and increasing the number prescribed a cholesterol-lowering drug from about 13 million to about 36 million, according to the NIH.

"The Cholestech L-D-X System is the only cholesterol testing device that is waived by the Federal Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) under the Clinical Laboratory Improvement Amendments Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.  (CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a ) and that can provide a complete Lipid Profile. We believe the L-D-X system is the most practical, economic and efficient means to address this widespread need for convenient, accurate cholesterol testing on the market today," said Warren E. Pinckert, president and chief executive officer of Cholestech Corporation. "The combination of our proprietary technology with the growing health testing service capability of our WellCheck(TM) business unit, positions us to be ready to provide health care providers with the tools and information that they need to meet these new guidelines issued by the NIH."

"For example, the new guidelines include a recommendation for a complete lipoprotein lipoprotein (lĭp'əprō`tēn), any organic compound that is composed of both protein and the various fatty substances classed as lipids, including fatty acids and steroids such as cholesterol.  profile as the preferred initial test. This profile includes total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides Triglycerides
Fatty compounds synthesized from carbohydrates during the process of digestion and stored in the body's adipose (fat) tissues. High levels of triglycerides in the blood are associated with insulin resistance.
. The Cholestech L-D-X Lipid Profile test cassette is the only CLIA waived multi-test device able to provide test results for these four lipoproteins recommended in the new guidelines from a single device using a single drop of blood, in less than 5 minutes," said Pinckert. "The L-D-X system can then provide the Framingham Risk Assessment from the patient's results as measured on the Lipid Profile cassette."

"Americans at high risk for a heart attack are too often not identified and, so, don't receive sufficiently aggressive treatment," said NHLBI NHLBI,
n.pr See National Heart, Lung, and Blood Institute.
 director Dr. Claude Lenfant. "Yet, studies show conclusively that lowering the level of low-density lipoprotein, or LDL LDL - ["LDL: A Logic-Based Data-Language", S. Tsur et al, Proc VLDB 1986, Kyoto Japan, Aug 1986, pp.33-41]. , the 'bad cholesterol,' can reduce the short-term risk for heart disease as much as 40 percent." Dr. Scott Grundy, ATP ATP: see adenosine triphosphate.
ATP
 in full adenosine triphosphate

Organic compound, substrate in many enzyme-catalyzed reactions (see catalysis) in the cells of animals, plants, and microorganisms.
 III chairperson and director of the Center for Human Nutrition at the University of Texas Southwestern Medical Center at Dallas The University of Texas Southwestern Medical Center at Dallas (also known as “UT Southwestern”) is a medical research center in Texas, USA.

It is one of the leading academic medical centers in the world.
 said, "The new guidelines will help doctors determine heart attack risk more precisely than was possible before. That allows treatment to be more individualized. We now know that cholesterol-lowering treatment is more effective when its intensity closely matches the level of risk."

"We believe our L-D-X system is not only ideal as a heart risk assessment tool, with our ALT (liver enzyme) test, it's equally effective for monitoring patients' therapeutic options. We are pleased that the NIH is taking aggressive measures to reduce the risk of heart disease among Americans and that Cholestech is able to participate in the effort to save more lives," said Pinckert.

About Cholestech

Cholestech is committed to helping people successfully improve their health. The Cholestech business units of Diagnostic Products and WellCheck(TM) can provide simple, accessible and reliable personal health information to health care practitioners and consumers in over 35 countries around the world. Cholestech offers efficient and economic diagnostic screening for cholesterol, blood sugar and liver function. Health care providers can use the Cholestech L-D-X System to monitor the progress of patient therapy. By providing effective

disease management solutions, Cholestech's goal is to ultimately enable people to lead longer, healthier and more active lives.

Safe Harbor Statement of Cholestech Corporation Under the Private

Securities Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 Reform Act of 1995:

This release contains forward-looking statements as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995, including statements regarding: the expected expansion of the number of Americans being treated for high cholesterol and the Company being ready to provide health care providers with tools and information to meet new NIH guidelines. Actual results may differ materially from those in the forward-looking statements due to risks and uncertainties including: regulatory changes affecting the health care system in the United States, changing relationships with customers, suppliers and strategic partners and the loss of a significant customer, and other factors.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:May 17, 2001
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