Cholestech Announces CLIA Waiver for Liver Function Testing of Alanine Aminotransferase - ALT - from Food & Drug Administration.HAYWARD, Calif.--(BW HealthWire)--April 17, 2001 Addition of ALT Test to Cholestech's Portfolio of CLIA-Waived Products Broadens Appeal of Cholestech L.D.X(R) System; Physicians and Other Health Care Professionals Can Screen for Chronic Diseases of the Cardiovascular and Hepatic Systems, and Monitor the Effects of Therapy for These Chronic Diseases 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) ) today announced that its liver function test, alanine aminotransferase alanine aminotransferase /al·a·nine ami·no·trans·fer·ase/ (ah-me?no-trans´fer-as) alanine transaminase. alanine aminotransferase n. Abbr. ALT See SGPT. (ALT), has received the Federal Drug Administration's (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. ) waiver under the Clinical Laboratory Improvement Act (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 ). This classification establishes Cholestech's ALT product as a unique diagnostic test for health care professionals to easily, reliably and conveniently assess their risk for certain liver-related diseases. Cholestech's ALT product was 510(k) cleared by the FDA in September of 1999. The Company anticipates launching ALT as "waived under CLIA" on June 1, 2001. The Cholestech ALT test will run on the Cholestech L.D.X System -- which delivers results with the same precision and accuracy as traditional testing methods, all on a single drop of blood in less than five minutes. The CLIA-waived ALT test further broadens the capabilities of Cholestech's line of personal health management solutions for chronic diseases, which include the Cholestech L.D.X System, WellCheck and WellCheck.com. "With the addition of the ALT test, the Cholestech L.D.X System will provide a new level of diagnostic testing Diagnostic testing Testing performed to determine if someone is affected with a particular disease. Mentioned in: Von Willebrand Disease convenience for healthcare professionals involved with monitoring the effects of lipid lowering and other drug therapies," said Warren Pinckert, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Cholestech Corporation. "Through our technology, health care professionals are better able to manage and improve their patients' health by quickly and reliably assessing their risks for high cholesterol Cholesterol, High Definition Cholesterol is a fatty substance found in animal tissue and is an important component to the human body. It is manufactured in the liver and carried throughout the body in the bloodstream. , and monitoring the progress of therapy." It is estimated that over 300 million people suffer from high cholesterol in the seven major markets of the world, equaling approximately 45 percent of the population(1). $15.8 billion was spent on statin drug Noun 1. statin drug - a medicine that lowers blood cholesterol levels by inhibiting HMG-CoA reductase lipid-lowering medication, lipid-lowering medicine, statin therapy in 1999 to treat this disease. With the growing use of these effective lipid-lowering therapies comes an increased need to monitor ALT -- also known as serum glutamic-pyruvic transaminase glutamic-pyruvic transaminase n. Abbr. GPT See SGPT. glutamic-pyruvic transaminase abbreviated GPT; see alanine aminotransferase. (SGPT SGPT serum glutamic-pyruvic transaminase; see alanine transaminase. SGPT n. Serum pyruvate aminotransferase; an enzyme in serum and body tissues that catalyzes the transfer of amino acid groups from ). A side effect of these drugs can be a persistent increase in serum ALT levels, to more than 3 times the upper limit of normal, in about 1% of the patients receiving such therapy, resulting in damage to their liver. ALT quantitative measurements are used by physicians in the diagnosis and treatment of certain liver diseases such as viral hepatitis viral hepatitis n. Any of various forms of hepatitis caused by a virus. viral hepatitis, n an inflammatory condition of the liver, caused by the hepatitis viruses: A, B, C, delta, E, F, G, or H. and cirrhosis, as well as heart diseases. "The medical community often takes a traditional approach to the adoption of new technologies. As the first liver enzyme test to be CLIA-waived, we expect sales of this product to begin slowly and anticipate that revenues from ALT will be immaterial to the Company's consolidated sales and revenue in the coming twelve months," said Pinckert. "Low reimbursement rates in the U.S. for ALT -- currently $7.32 per test under medicare -- means that we will not enjoy as high a gross margin as with our Lipid Profile lipid profile, n a series of tests used to gauge a person's risk for coro-nary heart conditions. Blood levels examined in a lipid profile include those for total cholesterol, LDL- and HDL-cholesterol, and triglycerides. ." The Company's ALT test for the Cholestech L.D.X System is available for immediate shipment at a list price of $45.00 U.S. in boxes of 10 cassettes each. About Cholestech Cholestech is committed to helping people lead longer, healthier and more active lives. Working together, the Cholestech business units of Diagnostic Products, WellCheck(TM), and WellCheck.com can provide simple, accessible and reliable personal health information to health care practitioners and consumers in over 35 countries around the world. By offering efficient and economic diagnostic screening for cholesterol, blood sugar and liver function, Cholestech hopes to help more people understand whether or not they face potentially serious health risks. Therapeutic monitoring options using the Cholestech L.D.X(R) System can help patients monitor their progress as they work with their health care provider to reduce their risk of cardiovascular and other diseases. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement of Cholestech Corporation under 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: This release contains forward-looking statements as defined in the Private Securities Litigations Reform Act of 1995, including statements regarding: the anticipated launch date and the expected rate of adoption of Cholestech's ALT test; expected financial performance, including gross margins, for Cholestech's ALT test, and other economic factors which may affect the financial impact of ALT on Cholestech's financial performance. Actual results may differ materially from those in the forward-looking statements due to risks and uncertainties, including: those inherent in the development of technologies and businesses; unanticipated expenditures; changing relationships with customers, suppliers and strategic partners; potential contractual, intellectual property or employment issues; delays; the loss of a significant customer; the availability and pricing of competing products and services and the resulting effects on sales and pricing of our products and services; and other factors. Cholestech L.D.X(R), WellCheck(TM) and WellCheck.com are registered trademarks of Cholestech Corporation. All other trademarks mentioned in this document are the property of their respective owners. For more information about Cholestech and its products visit us on the web at www.cholestech.com. WellCheck.com is available to the general public at www.wellcheck.com. (1) Source: Datamonitor Cardiovision, 9/2000, Germany, France, UK, Italy, US, Japan, Spain |
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