Hycor Biomedical Announces FDA Clearance of Three Autoimmune Test Kits.

GARDEN GROVE, Calif.--(BW HealthWire)--Oct. 6, 1999--

Hycor Biomedical Inc. (Nasdaq:HYBD) Wednesday announced that it has received clearance from the U.S. Food and Drug Administration to market its Anti-Cardiolipin IgG (ACA), Anti-Gastric Parietal Cell (GPC) and Anti-Glomerular Basement Membrane (GBM) ELISA Autoimmune tests in the United States.

These kits detect the presence of antibodies associated with anti-phospholipid syndrome (ACA), pernicious anemia (GPC) and Goodpasture's syndrome (GBM). While the relative incidences of these diseases are low, like other autoimmune disorders, they tend to increase as the population ages.

Anti-phospholipid antibodies have been reported in up to 2% of the normal population. Occasionally, they are associated with various infections and the ingestion of certain drugs. However, when present in active autoimmune disease, the patient can suffer from abnormal clotting in veins and arteries, spontaneous abortion and abnormally low platelet counts in addition to other illnesses.

Roughly, one in 1,000 people have pernicious anemia in which the lining of the stomach can no longer adequately absorb vitamin B12. Pernicious anemia is the end result of atrophic gastritis, which affects up to 30% of 60 year olds and up to 50% of 70 year olds and is associated with other autoimmune endocrine disorders.

Goodpasture's syndrome is rare, affecting about 1 in 100,000 people, usually men aged 16 to 61 years. The kidney is the organ affected in this disorder, which is characterized by excretion of protein and blood in the urine that progresses rapidly to kidney failure.

Hycor's tests, which are based on enzyme immunoassay technology in a microplate format, are intended to replace older methodologies including immunofluorescence methods, which are manual tests performed on cellular substrates or tissue sections and require a highly skilled technologist reading one test at a time through a microscope.

"We are pleased to have obtained marketing clearance for three more of our autoimmune disease tests," stated J. David Tholen, president and chief executive officer.

"We now have a total of 18 different tests cleared, four additional filings pending at the FDA, and we expect to file for six more tests by the end of 1999. This will make Hycor's autoimmune disease test menu one of the broadest available in the United States. Additionally, all the tests can be performed using a manual procedure, as well as in a fully automated mode on the new HY-TEC 288 automated immunoassay system."

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, and urinalysis controls and disposable products under the KOVA(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. 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.

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.