Hycor Biomedical Announces FDA Clearance of Autoimmune Kit.Business Editors and Health/Medical Writers BIOWIRE2K GARDEN GROVE, Calif.--(BW HealthWire)--Feb. 3, 2000 Hycor Biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. Inc. (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 :HYBD) today announced that it has received clearance from the U.S. Food and Drug Administration to market its Anti-Cardiolipin Screen ELISA ELISA (e-li´sah) Enzyme-Linked Immuno-Sorbent Assay; any enzyme immunoassay using an enzyme-labeled immunoreactant and an immunosorbent. ELISA n. autoimmune test in the United States. This latest FDA-cleared product is a complement to Hycor's previously cleared Anti-Cardiolipin IgG and Anti-Cardiolipin IgM.autoimmune kits. The Anti-Cardiolipin kits detect the presence of antibodies associated with antiphospholipid syndrome. Patients with antiphoslipid syndrome suffer from venous thrombosis (blood clots Blood Clots Definition A blood clot is a thickened mass in the blood formed by tiny substances called platelets. Clots form to stop bleeding, such as at the site of cut. ), arterial thrombosis (stroke, heart attack) or frequent pregnancy loss. Patients are generally treated for their symptoms with anticoagulant therapy anticoagulant therapy Hematology The use of anticoagulants to prevent intravascular clot formation, or dissolve clots that have already formed Indications DVT/thrombophlebitis, CAD, TIA/stroke, dysrhythmia, prosthetic heart valve, cancer Monitoring Serial . There is no known cure for this disease. With the clearance of the Anti-Cardiolipin Screen, a patient can be screened for the presence of these antibodies. If the screen is positive, reflex testing can then be done for Anti-Cardiolipin IgG and IgM using the previously cleared kits. Anti-phospholipid antibodies have been reported in up to 2% (12,000,000) of the normal population. &uot;We are pleased to have obtained marketing clearance for another of our autoimmune disease autoimmune disease, any of a number of abnormal conditions caused when the body produces antibodies to its own substances. In rheumatoid arthritis, a group of antibody molecules called collectively RF, or rheumatoid factor, is complexed to the individual's own gamma tests,&uot; stated J. David Tholen, president and chief executive officer. &uot;We now have a total of 23 different tests cleared and one additional filing pending at the 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. . This will make Hycor's autoimmune disease test menu one of the broadest available in the U.S. Additionally, all the tests can be performed using a manual procedure as well as in a fully automated mode on the new HY-TEC(TM) 288 automated immunoassay Immunoassay An assay that quantifies antigen or antibody by immunochemical means. The antigen can be a relatively simple substance such as a drug, or a complex one such as a protein or a virus. system. This same system also runs Hycor's allergy tests for over 900 specific allergens.&uot; Hycor's tests, which are based on enzyme immunoassay technology in a microplate format, are intended to replace older methodologies including immunofluoresence methods, which are manual tests requiring a highly skilled technologist reading one test at a time through a microscope. Hycor Biomedical Inc. discovers, develops, manufactures and markets diagnostic products for a variety of human medical conditions. These products include high quality automated instrument and reagent systems that use blood samples to test for more than 900 different allergens and autoimmune disorders, and urinalysis controls and disposable products under the KOVA KOVA Kobuk Valley National Park (US National Park Service) (R) brand, the market leader in standardized microscopic urinalysis. Hycor products are used by physicians and clinical laboratories all over the world to provide accurate, reliable test results for physicians and their patients. Headquartered in Garden Grove, California Garden Grove is a city centrally located in northern Orange County, California, United States. As of 2004, the city population was 170,000 people. California State Route 22, also known as the Garden Grove Freeway, passes through the city from east to west. with facilities in Germany, Scotland and France, Hycor employs more than 175 people worldwide and serves customers in more than 50 countries. Visit Hycor Biomedical's web site at http://www.hycorbiomedical.com. The matters discussed in this report are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from the results anticipated in the forward looking statements. These risks and uncertainties include, but are not limited to, economic, competitive, governmental and technological factors affecting the Company's operations, markets, products, services and prices and other factors discussed in the Company's filings with the Securities and Exchange Commission. |
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