Hycor Biomedical Announces FDA Clearance Of ANA-ELISA Test

GARDEN GROVE, CALIF. (March 3) BW HEALTHWIRE -March 3, 1999--Hycor Biomedical Inc. (Nasdaq:HYBD) Wednesday announced that it has received clearance from the U.S. Food and Drug Administration to market its ANA-ELISA test in the United States.

ANA-ELISA measures the presence of anti-nuclear antibodies associated with systemic lupus erythematosus and a number of other autoimmune diseases. The ANA-ELISA, which is based on enzyme immunoassay technology in a microplate format, is intended to replace the original immunofluorescence (IFA) screening 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 this product, since ANA is usually the first test run in the diagnostic work-up of suspected general autoimmune disease," stated J. David Tholen, president and chief executive officer.

"Since the prevalence of positives is up to 20 percent of the population, the ANA-ELISA permits the laboratory to screen large numbers of samples in an automated fashion and then confirm the fewer positive samples with the more tedious IFA method."

Hycor Biomedical 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, urinalysis controls and disposable products under the KOVA(R) brand, which is the market leader in standardized microscopic urinalysis.

Hycor products are used by physician's offices and clinical laboratories all over the world to provide accurate, reliable test results for physicians and their patients. With headquarters in Garden Grove, and facilities in Germany, Scotland and France, Hycor employs more than 175 people worldwide and serves customers in more than 50 countries.

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CONTACT: Hycor Biomedical Inc., Garden Grove

           Reg Jones, 714/933-3000 

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