Cholestech L.D.X. System receives waiver from key federal regulation; quick, accurate blood analyzer now more accessible for physicians, pharmacists, other health care providers.HAYWARD, Calif.--(BUSINESS WIRE)--Jan. 29, 1996--Cholestech Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CTEC CTEC Course and Teacher Evaluation Council (Northwestern University, Office of the Register) CTEC Certified Technical Education Center CTEC Certified Technical Education Center (Microsoft) ) announced today that its Cholestech L.D.X. System ("L.D.X. System"), which is used to conduct quick, accurate testing of cholesterols and glucose levels in the blood, has been waived 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. of 1988 ("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 ") by the Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. (CDC See Control Data, century date change and Back Orifice. CDC - Control Data Corporation ). This waiver, the only one granted by the CDC under its newly defined ease of use, accuracy and precision guidelines, enables physicians, medical clinics, pharmacists and other health care providers to use the system free from extensive regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. . The L.D.X. System, consisting of a portable blood analyzer and a family of disposable test cassettes, is the only product on the U.S. market that measures total cholesterol, HDL cholesterol HDL cholesterol n. See high-density lipoprotein. HDL Cholesterol About one-third or one-fourth of all cholesterol is high-density lipoprotein cholesterol. , 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. and glucose levels, and provides a calculated LDL cholesterol LDL cholesterol n. See low-density lipoprotein. LDL Cholesterol Low-density lipoprotein cholesterol is the primary cholesterol molecule. High levels of LDL increase the risk of coronary heart disease. from a single drop of blood in less than five minutes. It was designed by Cholestech to be operated without extensive training. Self-diagnostic software was built into the L.D.X. System to assure accurate readings. Due to these design features, Cholestech sought a change in status to "waived" for the L.D.X. System, meaning that it could be operated reliably by an untrained user. Under the prior classification of "moderately complex," users were required to undertake daily quality control measures, employ technically trained personnel and undergo proficiency testing and periodic inspections, as well as comply with other CLIA regulations. Cholestech estimates that this regulatory burden added at least $2,000 per year to the cost of operating the L.D.X. System, making it economically not viable for many potential customers. Current L.D.X. System users, including managed care organizations, hospitals, self-insured businesses and health promotion organizations, will now be able to use the system at a lower cost. Cholestech believes that there are many other health care providers, including physicians and pharmacists, who will now find the L.D.X. System to be a highly reliable and less expensive way to screen and monitor the blood lipid and glucose levels of their patients. In addition to its currently available test panels for the L.D.X. System, Cholestech is developing additional panels to conduct tests for prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. and bone loss (commonly associated with osteoporosis) and is exploring the feasibility of developing a range of other panels to conduct blood tests required in primary care situations. "We are extremely pleased to receive the first CLIA waiver from the CDC under the recently published guidelines, and we extend our appreciation to the CDC staff for their hard work in developing extensive protocols to evaluate products such as the L.D.X. System," said Warren E. Pinckert II, president and chief executive officer of Cholestech Corporation. He continued, "Our dedicated staff is also to be commended. We have spent more than three years making our case and developing extensive documentation to assure the CDC that the L.D.X. System is easy-to-use and accurate enough to render negligible the likelihood of erroneous results, the primary qualification for 'waived' status." Mr. Pinckert added, "For our existing customers, this waiver will make the L.D.X. System less costly to operate, while it opens the door for Cholestech to pursue several new U.S. markets, especially the 31,000 physician-office labs that currently conduct only "waived" tests. In addition, Cholestech is looking forward to marketing the L.D.X. System to pharmacies, where there is an emerging trend toward providing customers with greater services and support for their health care regimens." Cholestech recently announced that the L.D.X. System will be used in a pilot program with the 45,000-member American Pharmaceutical Association (APhA) to monitor patients in a pharmacy-based cholesterol management project. The program, funded by the Merck Human Health Division, is expected to initially include up to 30 pharmacies and 900 patients nationwide in a two-year study. Cholestech Corporation is a leading manufacturer of point-of-care screening and diagnostic equipment. Cholestech is uniquely positioned to benefit from the increasing emphasis on preventive health care and disease management worldwide. Cholestech's portfolio of products is designed to offer efficient and economic screening and monitoring options that will ultimately enable people to lead longer, healthier and more active lives. CONTACT: Cholestech Corporation Lola Moenich, 510/293-8096 or Edelman Public Relations public relations, activities and policies used to create public interest in a person, idea, product, institution, or business establishment. By its nature, public relations is devoted to serving particular interests by presenting them to the public in the most Jon Greer, 415/433-5381 |
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