IVAX Diagnostics Receives FDA Clearance for Anti-Cardiolipin Screen Assay and Submits Two New Products.

Business Editors/Health & Medical Writers

MIAMI--(BW HealthWire)--Aug. 28, 2001

IVAX Diagnostics, Inc. (AMEX:IVD) announced today that its wholly-owned subsidiary, Diamedix Corporation, based in Miami, Florida, has received marketing clearance from the U.S. Food and Drug Administration (FDA) for its Anti-Cardiolipin Screen immunosimplicity(R) test kit, an Enzyme Immunoassay (EIA) procedure for assessing the risk of thrombosis in patients with systemic lupus erythematosus (SLE) or other autoimmune diseases. Autoantibodies directed against phospholipids and anti-cardiolipin, in particular, have been associated with venous thrombosis, arterial thrombosis and spontaneous abortions. The term "anti-phospholipid syndrome" is often used to describe these conditions.

In addition, IVAX Diagnostics announced today that Diamedix has filed two new 510(k) pre-market notification submissions to the FDA seeking marketing clearance for its immunosimplicity(R) test kits: Anti-Gliadin IgG and Anti-Gliadin IgA. These two Anti-Gliadin kits are Enzyme Immunoassay (EIA) procedures for the quantitative detection of gliadin antibodies that can assist physicians in the diagnosis of certain gluten sensitive enteropathies such as celiac disease, dermatitis herpetiformis, and atopic dermatitis. Celiac disease is a chronic condition that is characterized by sensitivity to gluten that results in inflammation and atrophy of the mucosa of the small intestine resulting in a malabsorption syndrome.

The two Anti-Gliadin test kits are designed to be used manually or in conjunction with the MAGO(R) Plus system manufactured by IVAX Diagnostics' subsidiary, Delta Biologicals, S.r.l., based in Italy. Upon receipt of marketing clearance from the FDA, IVAX Diagnostics expects to begin marketing its two Anti-Gliadin test kits worldwide. IVAX Diagnostics believes that these new Anti-Gliadin assays will represent a significant addition to the menu of autoimmune assays that it already markets. Including the new clearance just received, IVAX Diagnostics currently markets 36 FDA-cleared immunosimplicity(R) test kits, primarily in the areas of autoimmune disease and infectious disease assays. This combination of test kits, instrumentation and proprietary software is intended to provide laboratories with an automated "walk-away" system enabling them to test for autoimmune and infectious diseases in an efficient, labor saving manner.

Giorgio D'Urso, CEO and president of IVAX Diagnostics said, "The receipt of FDA clearance for our Anti-Cardiolipin Screen Assay along with the two new submissions made for our Anti-Gliadin assays demonstrate our commitment to further expansion of our immunosimplicity(R) test kit menu. We believe this growing product line will allow us to continue to achieve greater market share with our MAGO(R) Plus automated immunoassay instrument."

About IVAX Diagnostics, Inc.

IVAX Diagnostics, Inc., headquartered in Miami, Florida, develops, manufactures and markets proprietary diagnostic reagents, instrumentation and software in the United States and Italy through its three subsidiaries: Diamedix Corporation, Delta Biologicals S.r.l. and ImmunoVision, Inc. IVAX Corporation (AMEX:IVX) owns approximately 70% of IVAX Diagnostics, Inc.

Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect the business and prospects of IVAX Diagnostics, Inc., including but not limited to the risks that its new instruments and products may not be approved by the FDA or may not prove to be commercially successful; that the MAGO(R) instrument may not be successfully introduced in additional markets; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in the company's Annual Report on Form 10K and other filings with the Securities and Exchange Commission.