CHATSWORTH, Calif., March 24, 2011 (GLOBE NEWSWIRE) -- IRIS International, Inc. (Nasdaq:IRIS), a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, and a provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, announced today that its Iris Diagnostics Division has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its iChem®VELOCITY™ Automated Urine Chemistry Analyzer and iRICELL® Urinalysis Workstation.
"We are delighted to receive this clearance which represents a major milestone for IRIS and is the culmination of a challenging regulatory review process. We are now poised to immediately commence the launch of iChemVELOCITY in the U.S., as well as in those countries which require regulatory approval in the country of origin. This is expected to result in gross margin improvement and greater profitability for our core urinalysis business in 2011 and beyond, and will significantly increase the pull-through of iChem test strips benefiting the utilization of our strip manufacturing facility in Marburg, Germany, which is already operating near breakeven," stated Cesar Garcia, Chairman, President and CEO of IRIS International.
"As the worldwide market leader in automated urinalysis microscopy, FDA clearance of the iChemVELOCITY represents a critical element in our strategy to provide both a stand alone automated urine chemistry analyzer and the iRICELL fully integrated urinalysis workstation globally. This gives us the opportunity to gain full access to and further penetrate the balance of the estimated $500 million worldwide urine chemistry market with improved gross margin through economies of scale," stated Thomas Warekois, President of the Diagnostics Division. "The iChemVELOCITY automated urine chemistry analyzer, combined with our series of leading iQ®200 automated urine microscopy analyzers, forms our portfolio of iRICELL Urinalysis Workstations, significantly enhancing and rounding out our core urinalysis business. We are now in a position to expand our market share by offering customers in the U.S. and globally, a fully integrated, bench top automated urinalysis solution under one platform," he added.
While pursuing U.S. regulatory clearance, IRIS received CE Mark certification and launched the iChemVELOCITY to the international marketplace in September 2008, and since that time has sold more than 300 instruments in more than 30 countries.
The iChemVELOCITY system is designed to deliver improved productivity and clinical utility in the medium to high volume hospital and clinical reference labs.
About IRIS International, Inc.
IRIS International, Inc. is a leading global in vitro diagnostics company focused on products that analyze particles and living cell forms and structures, or morphology of a variety of body fluids. The Company's products leverage its strengths in flow imaging technology, particle recognition and automation to bring efficiency to hospital and commercial laboratories. The initial applications for its technology have been in the urinalysis market and the Company is the leading worldwide provider of automated urine microscopy and chemistry systems, with an installed base of more than 3,000 systems in more than 50 countries. The Company is expanding its core imaging and morphology expertise into related markets, and is developing applications in hematology and body fluids. In addition, the Company recently acquired a high complexity CLIA-certified molecular pathology laboratory offering differentiated, high value molecular diagnostic services in the rapidly growing field of personalized medicine. The laboratory provides a direct commercial channel for the Company's NADiA® ultra-sensitive nucleic acid detection immunoassay platform, with applications in oncology and infectious disease. For more information, please visit www.proiris.com.
SAFE HARBOR PROVISION
This press release contains forward-looking statements made in reliance upon the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, the Company's views on future financial performance, market growth, capital requirements, regulatory developments, new product introductions and acquisitions, and are generally identified by phrases such as "thinks," "anticipates," "believes," "estimates," "expects," "intends," "plans," and similar words. Forward-looking statements are not guarantees of future performance and are inherently subject to uncertainties and other factors which could cause actual results to differ materially from the forward-looking statement. These statements are based upon, among other things, assumptions made by, and information currently available to, management, including management's own knowledge and assessment of the Company's industry, R&D initiatives, competition and capital requirements. Other factors and uncertainties that could affect the Company's forward-looking statements include, among other things, the following: identification of feasible new product initiatives, management of R&D efforts and the resulting successful development of new products and product platforms; obtaining regulatory approvals for new and enhanced products; acceptance by customers of the Company's products; integration of acquired businesses; substantial expansion of international sales; reliance on key suppliers; the potential need for changes in long-term strategy in response to future developments; future advances in diagnostic testing methods and procedures; potential changes in government regulations and healthcare policies, both of which could adversely affect the economics of the diagnostic testing procedures automated by the Company's products; rapid technological change in the microelectronics and software industries; and competitive factors, including pricing pressures and the introduction by others of new products with similar or better functionality than our products. These and other risks are more fully described in the Company's filings with the Securities and Exchange Commission, including the Company's most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q, which should be read in conjunction herewith for a further discussion of important factors that could cause actual results to differ materially from those in the forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.