FDA grants IRIS clearance for analysis of synovial fluid with iQ200, iRICELL automated microscopy analyzers

Sep 7 2010

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.