Hycor Biomedical announces FDA Clearance Of a Test for Diagnosis of Rheumatoid Arthritis.

Business/Health and Medical Writers

GARDEN GROVE, Calif.--(BW HealthWire)--March 14, 2000

Two million Americans have Rheumatoid Arthritis, which eats away cartilage and eventually erodes bone. It strikes mostly women, usually

between ages 25 and 50. Within 10 years, about half are too disabled to work. Like many other autoimmune diseases, rheumatoid arthritis is

treatable - if it's detected early.

Hycor Biomedical Inc. (NASDAQ: HYBD) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Rheumatoid Factor (RF) IgA ELISA autoimmune test in the United States. The Hycor RF IgA test completes Hycor's panel of tests for Rheumatoid Arthritis (RA) and complements the RF IgM and RF IgG tests previously cleared for marketing by FDA.

Early diagnosis of RA is critical as it can make the difference between being able to continue with everyday life (under moderate restrictions), becoming disabled or being bedridden. Patients with less destructive forms of the disease can be managed with rest and anti-inflammatory agents, while patients with more aggressive disease require drugs, in addition to anti-inflammatory agents. Left untreated, RA may shorten life expectancy.

"We are pleased to have obtained marketing clearance for another of our autoimmune disease tests," stated J. David Tholen, president and chief executive officer. "We now have a total of 25 different tests cleared by the FDA and expect to complete another filing by the end of the second quarter. Hycor's autoimmune disease test menu is 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 our new HYoTEC 288 automated immunoassay system. This same system also runs Hycor's allergy tests for over 900 specific allergens."

Autoimmune diseases, which have long been considered rare, have been moved to the top of the national women's research agenda by the National Institutes of Health (NIH), according to Vivian W. Pinn, M.D., director of NIH's Office of Research on Women's Health (ORWH).

Rheumatoid Factor is an autoantibody that can be found in 80 percent of patients with Rheumatoid Arthritis (RA), a chronic disease characterized by periods of disease flares and remissions that afflicts approximately 1 percent of Americans, mostly women. During flares, joints become red, swollen, painful and tender. The inflammation is usually symmetrical, occurring on both sides of the body, and can cause permanent joint destruction and deformity. Although RA can afflict children and adolescents, the disease usually strikes adults between the ages of 25 and 50, with the incidence of clinical disease greatest among those aged 40 to 60 years.

While RF has long been useful in the diagnosis of Rheumatoid Arthritis, and other autoimmune connective tissue diseases, it is only in recent years that it has become recognized that multiple antibody types, i.e. IgA and IgG, as well as IgM, contribute to Rheumatoid Factor. Published studies indicate that the prevalence of these various antibody types may help differentiate similar diseases with different treatments and outcomes. With the approval of the AUTOSTAT II IgA RF test, Hycor can now offer assays for all three major classes of Rheumatoid Factor antibody

Hycor's tests, which are based on enzyme immunoassay technology in a microplate format, are intended to replace older methodologies, including agglutination methods, which are labor-intensive manual tests subject to difficulties in interpretation. The ELISA tests can also be run on Hycor's HYoTEC(TM) fully automated immunoassay systems.

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(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 with facilities in Germany and Scotland, 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.