IVAX Diagnostics' Diamedix Subsidiary Files 510(k) Premarket Submission with FDA for Its Mago®4S

-- Key Enhancements Over Currently Available Product Include Ability to Simultaneously Process Samples in ELISA and IFA --

• Press Release
• Source: IVAX Diagnostics, Inc.
• On 7:30 am EDT, Thursday October 1, 2009

MIAMI--(BUSINESS WIRE)--IVAX Diagnostics, Inc. (AMEX: IVD - News) announced today that its U.S. subsidiary headquartered in Florida, Diamedix Corporation, has filed a 510(k) premarket submission with the U.S. Food and Drug Administration (“FDA”) for its next -generation fully automated Enzyme-linked Immunosorbent Assay (“ELISA”) system for autoimmune and infectious disease testing, named the Mago®4S. IVAX Diagnostics believes the new instrumentation will provide a flexible, efficient and cost-effective solution to today's high-performance laboratory demands.

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Key enhancements of the Mago®4S compared to the current Mago® Plus available in the U.S. are:

• Ability to process samples in ELISA and Immunoflourescence Assays (“IFA”) methods simultaneously. This walk away and random access system will be capable of performing Infectious Disease tests (ELISA and/or IFA) or Autoimmune tests (ELISA and/or IFA).
• Expanded capabilities with embedded Windows® XP software architecture and programming that allows interpretation, storage and recall of results, standard curves and internal quality control (“QC”), and retrieval of archived data.
• Ability to perform up to 12 ELISA tests or up to 16 IFA tests or a combination in parallel, with any combination of 4 ELISA plates/IFA slide holders.
• Time saving set-up procedures and features, such as easy, fast-loading holders for IFA slides.
• Ability to export data to an external PC; e.g., for use with Levey-Jennings or Westgard QC rules.
• Improved workflow with pre-programmed and reagent partners programmed tests performing in parallel.
• Consolidated space requirements with a built in Microsoft Windows XP® Professional computer eliminating the need for a separate workstation.

Dr. Charles Struby, CEO and President of IVAX Diagnostics said, “The Mago®4S was introduced at the American Association for Clinical Chemistry Expo in July where the instrumentation’s potential to address the critical needs of the reference laboratory manager was met with great interest. We perceived there to be a great amount of excitement surrounding the new system, and we look forward to proceeding through the FDA process and making this product commercially available following our receipt of regulatory approval. We are also continuing our efforts to introduce similar analyzer instrumentation in countries outside the U.S.”

He concluded, “We believe that the future commercial release of this product, combined with our recent distribution agreements, brings IVAX Diagnostics yet another step closer towards creating a stronger and more competitive company by distributing test kits that meet and/or exceed patients’ and their physicians’ needs for accurate and efficient in vitro diagnosis.”

About IVAX Diagnostics, Inc.

IVAX Diagnostics, Inc. (www.ivaxdiagnostics.com), headquartered in Miami, Florida, is a fully integrated in vitro diagnostics company that develops, manufactures and distributes in the United States and internationally, proprietary diagnostic reagents, test kits and instrumentation, primarily for autoimmune and infectious diseases, through its three subsidiaries: Diamedix Corporation, Delta Biologicals S.r.l. and ImmunoVision, Inc.

Safe Harbor Statement

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, without limitation: the risks and uncertainties relating to the Mago®4S, including, without limitation, the risk that IVAX Diagnostics may not receive regulatory approval for the Mago®4S when expected, or at all, the risk that the Mago®4S will not be available when expected, or at all (whether as a result of a delay in receipt of, or failure to receive, regulatory approval for the Mago®4S or otherwise), and the risk that, even if IVAX Diagnostics receives regulatory approval for the Mago®4S and commences the commercial distribution of the Mago®4S, the Mago®4S may not provide a flexible, efficient and cost-effective solution to today's high-performance laboratory demands or otherwise address the critical needs of the reference laboratory manager, IVAX Diagnostics may not successfully market the Mago®4S, the Mago®4S may not be well accepted in the marketplace (whether as a result of the advantages of the Mago®4S described in this press release not being realized or otherwise), IVAX Diagnostics’ customers may not integrate the Mago®4S into their operations, the Mago®4S may not perform as expected, be a source of revenue growth for IVAX Diagnostics, be a factor in IVAX Diagnostics’ growth, expand the menu of test kits that IVAX Diagnostics offers or otherwise result in IVAX Diagnostics receiving financial benefits or achieving improved operating results, and the Mago®4S, combined with IVAX Diagnostics’ recent distribution agreements, may not result in IVAX Diagnostics being a stronger and more competitive company (whether through its distribution of test kits that meet and/or exceed patients’ and their physicians’ needs for accurate and efficient in vitro diagnosis or otherwise); the risk that IVAX Diagnostics’ efforts to introduce analyzer instrumentation similar to the Mago®4S in countries outside the U.S. may not be successful; 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 risks and uncertainties set forth above, investors should consider the economic, competitive, governmental, technological and other risks and uncertainties discussed in IVAX Diagnostics’ filings with the Securities and Exchange Commission, including, without limitation, the risks and uncertainties discussed under the heading “Risk Factors” in such filings.

IVAX Diagnostics, Inc.
Dr. Charles R. Struby, CEO & President, 305-324-2300
or
Investor Relations:
Porter, LeVay & Rose, Inc.
Linda Decker, Vice President, 212-564-4700