IRIS International Granted European Patent for NADiA(R) Ultra-Sensitive Protein Detection and Cell Phenotyping Platform


CHATSWORTH, Calif., Oct. 14, 2010 (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, today announced that Iris Molecular Diagnostics (IMD)has been granted Patent No. EP1842226B1 by the European Patent Office (EPO) covering aspects of IMD's NADiA® ultra-sensitive protein detection and cell phenotyping platform, which can detect proteins in the femtogram (1 quadrillionth) per milliter range and phenotype single cells.

The patent, entitled "Homogenous Analyte Detection," is based on technology that eliminates the need for solid phase incubation and wash steps that greatly simplifies assays on the NADiA® (Nucleic Acid Detection Immunoassay) platform. The patent, which is effective through November of 2024, will be in force in 14 designated European countries, including Austria, Belgium, Denmark, Germany, Ireland, Italy, Finland, France, Portugal, Spain, Switzerland, Sweden, Turkey, and the United Kingdom. IMD is also seeking patent protection for this technology in the US, Australia, Canada, Japan, China and South Korea.

"We are delighted to have been granted this first broad patent including embodiments of the NADiA® method in its most flexible and efficient homogenous format, which is more compatible with automated instruments platforms," stated Dr. Thomas Adams, IRIS Chief Technology Officer. "Our technology enables the in-solution detection of proteins, viruses, bacteria, cells and other materials, which are then measured using PCR amplification," he added.

To date, Iris Molecular Diagnostics has filed 17 national and international patent applications, seeking coverage of various aspects of the NADiA® platform. For example, IMD is seeking patent protection worldwide on its NADiA® Displacement Technology for protein detection that is expected to enable the detection of proteins present at lower than femtogram per millimeter concentration [in the attogram (1 quintillionth) per milliliter range] and also for its NADiA® ProsVue™ technology which aids in the identification of patients at low risk of cancer recurrence post-radical prostatectomy.

IMD is the exclusive licensee of three issued patents from the University of California in the field of Immuno-PCR technology for ultra-sensitive protein detection.

The NADiA® technology is a molecular diagnostics platform targeting the early detection of relapse of cancer and infectious diseases utilizing a novel ultra-sensitive and precise method for the detection of proteins. It is capable of performing these assays on real-time Polymerase Chain Reaction (PCR) systems, which are already in use in laboratories performing esoteric tests and for amplification and quantification of DNA. The technology has the ability to rapidly and effectively measure extremely low concentrations of proteins, which are under the detection threshold of current immunoassay methods.

About IRIS International

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 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 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.  



            

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