IRIS Receives FDA 510(k) Clearance for Analysis of Synovial Fluid Utilizing Its iQ(R)200 Series Automated Microscopy Analyzers

/ Source: GlobeNewswire

CHATSWORTH, Calif., Sept. 7, 2010 (GLOBE NEWSWIRE) -- IRIS International, Inc. (Nasdaq:IRIS), a leading manufacturer of automated in-vitro diagnostic systems and consumables for use in hospitals and commercial laboratories worldwide and provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the analysis of synovial fluid as a new product application in its Body Fluids Module utilizing its iQ®200 and iRICELL® automated microscopy analyzers.

"This latest approval for synovial fluid analysis, the second-most prescribed body fluid test after cerebrospinal fluid, significantly rounds-out our Body Fluids Module for the analysis of critical body fluids other than urine, and increases the overall clinical utility of our iQ200 and iRICELL series of automated urinalysis microscopy systems," stated Cesar Garcia, Chairman, President and Chief Executive Officer of IRIS. "We now offer a complete body fluids menu including cerebrospinal, pleural, peritoneal, pericardial, general serous and synovial fluids," he added.

"As a result of the frequency of the test, by adding synovial fluid analysis capabilities, we can positively impact manual labor and help to standardize a rather large volume specialty test with minimal workflow interruptions," stated Thomas Warekois, President of the Iris Diagnostics Division. "Body fluids is performed in the majority of our target hospitals and laboratories on the iQ200, and this extended body fluid application allows us to approach additional hospital laboratories for sales of our automated microscopy systems and related consumables, as it may enable hospitals with lower volume of urinalysis tests to justify the purchase of our equipment, instead of continuing the manual microscopy approach."

Synovial fluid is a highly viscous material that is present in many of the joints of the body. It serves the purpose of lubricating and nourishing certain parts of the joint.  Synovial (joint) fluid analysis may be ordered to help diagnose the cause of joint inflammation, pain, swelling, and fluid accumulation, associated with such disorders as acute and chronic septic arthritis due to bacterial infection, autoimmune disorders including rheumatoid arthritis and systemic lupus erythematosus, and degenerative diseases such as osteoarthritis.

The Body Fluids Module for automated body fluids analysis is offered as a separate software option for the iQ200 analyzer and is expected to generate incremental recurring revenue through the use of the Company's proprietary consumables. This application enables a laboratory to analyze a suite of body fluids and urine samples on its existing iQ200 instrument using the Company's patented digital imaging technology.

The iQ200, when combined with the Company's iChem®VELOCITY™ automated chemistry analyzer, forms the iRICELL workstation, providing a fully integrated and automated system for managing the workload of urine microscopy and urine chemistry testing, as well as body fluids analysis. The iChemVELOCITY is currently sold in the international market and is pending U.S. FDA 510(k) clearance.

About IRIS International

IRIS International 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 2,800 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 urinary tract infections. 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 .


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 in this news release include, but are not limited to, statements relating to the Company's views on the features and benefits of the synovial fluid application, including the Company's expectation that it will result in an expanded market for the Company's microscopy analyzers and proprietary consumables, 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 features and benefits of the new synovial fluid application; the market for synovial fluid analysis; the benefits of automated vs. manual synovial fluid testing; the willingness of small customers to invest in automated microscopy due to the introduction of synovial fluid to the Body Fluids Module product suite; adoption of the product by hospitals and laboratories; and competition from existing and newly introduced products that compete with the Company's 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.

CONTACT: IRIS International, Inc. Cesar Garcia, Chairman and Chief Executive Officer 818-709-1244 The Wall Street Group, Inc. Ron Stabiner 212-888-4848