To: Rock_nj who wrote (86773 ) 7/28/1999 9:51:00 AM From: flyboy Respond to of 119973
No volume yet but...Wednesday July 28, 6:04 am Eastern Time Company Press Release Hycor Biomedical Announces FDA Clearance of Anti-Pr-3 ELISA Test GARDEN GROVE, Calif.--(BW HealthWire)--July 28, 1999--Hycor Biomedical Inc. (Nasdaq:HYBD - news) today announced that it has received clearance from the U. S. Food and Drug Administration to market its Anti-Pr-3 (C-ANCA) ELISA Autoimmune test in the United States. Anti-Pr-3 measures the presence of antibodies associated with Wegener's granulomatosis. The Anti-Pr-3 ELISA test, which is based on enzyme immunoassay technology in a microplate format, is intended to replace the original immunofluorescence (IFA) method, which is a manual test performed on a microscope slide that requires a highly skilled technologist reading one test at a time through a microscope. ''We are pleased to have obtained marketing clearance for another one of our autoimmune disease tests,'' stated J. David Tholen, president and chief executive officer. ''We now have a total of 15 different tests cleared, three additional filings pending at the FDA, and we expect to file for ten more tests by the end of 1999. This will make Hycor's autoimmune disease test menu one of the broadest available in the U.S. Additionally, all the tests will be capable of being performed in both a manual procedure as well as in a fully automated mode on the new HY-TEC 288 automated immunoassay system.'' 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. 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 allergies and autoimmune disorders, and urinalysis controls and disposable products under the KOVA® brand, the market leader in standardized microscopic urinalysis. Hycor products are used by physician's office and clinical laboratories all over the world to provide accurate, reliable test results for physicians and their patients. Headquartered in Garden Grove, California with facilities in Germany, Scotland, and France, Hycor employs more than 175 people worldwide and serves customers in more than 50 countries.