Healthcare Industry News:  tumor marker 

Diagnostics Oncology FDA

 News Release - February 7, 2007

IRIS Submits 510(k) Application To FDA For Its N.A.D.I.A. Prostate Cancer Test

CHATSWORTH, Calif.--(HSMN NewsFeed)--IRIS INTERNATIONAL, INC. (NASDAQ: IRIS ) today announced that its Iris Molecular Diagnostics (IMD) subsidiary has filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for its ultra-sensitive Prostate-Specific Antigen (PSA) test. The Nucleic Acid Detection Immuno Assay (NADIA) technology utilized to develop the ultra-sensitive PSA test was compared to a commercially available test and compared well across the assay range with improved sensitivity at low concentrations. NADIA PSA is to be used for monitoring prostate cancer patients following therapy.

"We are pleased to file an FDA application for the first product to emerge from our IMD subsidiary, which was formed by the acquisition of Leucadia Technologies in April of 2006," stated IRIS President and Chief Executive Officer Cesar Garcia. "Our NADIA platform technology combines nucleic acid and immuno-assay detection techniques to enable ultra-sensitive detection of low concentrations of proteins. Depending on the FDA clearance process, we anticipate launching the PSA product into this important niche segment by the end of 2007. We congratulate Dr. Thomas Adams and his team of IMD scientists for this achievement."

Dr. Thomas Adams, Corporate Vice President and Chief Technology Officer of IRIS International, led the development of the Company's NADIA PSA test. He also led the team that developed the first PSA test to receive FDA clearance while working as Chief Technology Officer at Hybritech, Inc., in the 1980s. He is recognized as a leader in the development of innovative scientific breakthroughs in diagnostic testing. Dr. Adams and the Hybritech team were recently recognized for their work on the PSA test by CONNECT, a globally renowned organization affiliated with the University of California at San Diego which fosters life sciences entrepreneurship, and which cited the PSA test as one of the most significant technology products ever created in San Diego, putting it in the company of Qualcom's CDMA technology and Biogen-Idec's Rituxan cancer drug.

The underlying technology for the PSA test developed by IMD is a proprietary protein diagnostics platform called Nucleic Acid Detection ImmunoAssay (NADIA), a novel ultra-sensitive method for the detection of proteins using nucleic acid labeled antibodies and the polymerase chain reaction that is many times more sensitive than conventional immunoassays. The assay is capable of being performed on instruments that are already in place in large laboratories.

Statistics show that some 230,000 men in the United States will be diagnosed with prostate cancer in 2007, and according to the Centers for Disease Control and Prevention, approximately 75% of them will undergo the removal of the prostate.

PSA remains the most important tumor marker to date for the diagnosis and clinical management of prostate cancer in men. The worldwide market for traditional PSA testing is estimated at more than $400 million annually, with more than $180 million in the U.S. alone. IMD's ultra-sensitive PSA test is intended for use in monitoring these cancer patients following therapy.

"IMD's ultra-sensitive PSA test represents the first of several high value stand alone protein diagnostic products to be developed using our novel and highly sensitive technology," stated Dr. Thomas Adams. "This is our first NADIA diagnostics test, which is expected to help us prove the efficacy and value of our platform technology. We will be conducting a retrospective clinical study within the next few months to establish the clinical utility of ultra-sensitive detection NADIA PSA. Other products under development utilizing our NADIA platform technology include an HIV viral load test to monitor the residual amounts of HIV in the blood of patients treated with anti-retroviral drugs which are undetectable by current diagnostic tests. This will be followed by a blood-based Her-2/neu test for monitoring breast cancer after a mastectomy or lumpectomy," he added.


IRIS International, Inc. (, based in Chatsworth, Calif., is a leader in automated urinalysis technology with systems in major medical institutions throughout the world. The Company's Sample Processing business unit (formerly the StatSpin® subsidiary), based in Westwood, Mass., manufactures innovative centrifuges and blood analysis products. Advanced Digital Imaging Research, LLC (ADIR), based near Houston, Texas, is the Company's imaging research and development subsidiary. The IRIS Molecular Diagnostics (IMD) Subsidiary develops innovative ultra-sensitive diagnostics and sample processing products with applications in the urinalysis, oncology and infectious disease markets.


This news 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, new product introductions and acquisitions, and are generally identified by phrases such as "thinks," "anticipates," "believes," "estimates," "expects," "intends," "plans," and similar words. Examples of forward-looking statements in this news release include the anticipated launch of the PSA product and its intended use in the marketplace, and future product initiatives for the Company's NADIA platform technology. 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; 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.

Source: IRIS International

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