The results of the retrospective study showed that the Ultrasensitive NADiA total PSA (tPSA) Assay reliably predicts prostate cancer bio chemical recurrence (BCR) after radical prostatectomy (RP). The Company’s NADiA PSA Assay detected levels and increasing levels of PSA that were previously undetectable using conventional ultra sensitive assays, thus potentially enabling the detection of BCR an average 2-1/2 years earlier than with the most sensitive commercially available tPSA assays. Research scientists analyzed stored leftover serum of 85 post-prostatectomy patients who were tested with the NADiA PSA Assay. A copy of the Scientific Poster Presentation of the NADiA tPSA Assay study results can be found on the IRIS web site at www.proiris.com. (Note: As of the date of this publication, NADiA PSA is considered an investigational assay and all product claims are subject to FDA clearance).
The study was performed by the Company’s Iris Molecular Diagnostics Group (IMD) in collaboration with Dr. Eleftherios P. Diamandis MD, PhD, Head of Clinical Biochemistry at the University of Toronto and Director of Pathology and Laboratory Medicine at Mt. Sinai Hospital in Toronto. Dr. Diamandis currently serves on boards of 25 scientific journals and has published more than 400 original papers. Dr. Diamandis has received numerous awards for his contributions to cancer research including most recently, Investigator of the Year Award from the American Association of Clinical Chemistry and the Morton K. Schwartz Award for Significant Contributions in Cancer Research Diagnostics. He currently serves as a consultant to Iris Molecular Diagnostics.
“Our findings could very well become the basis to monitor biochemical recurrence of PSA much earlier than conventional PSA assays,” said Chairman, President and Chief Executive Officer César García. “This study is an important milestone in our corporate history and we congratulate our IMD team and Dr. Diamandis for this significant achievement.”
ABOUT IRIS INTERNATIONAL, INC.
IRIS International, Inc. (www.proiris.com), based in Chatsworth, Calif., is a leading developer, manufacturer, and marketer of medical devices, diagnostic systems and consumables. The Iris Diagnostics Division (www.irisdiagnostics.com) is a leader in automated urinalysis technology with systems in major medical institutions throughout the world. Iris Molecular Diagnostics develops innovative ultra-sensitive diagnostics and sample processing products with applications in the urinalysis, oncology and infectious disease markets. The Company's Sample Processing business unit, formerly the StatSpin® subsidiary (www.statspin.com) based in Westwood, Mass., manufactures innovative centrifuges and sample preparation products.
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.
Contact:
IRIS International, Inc. César García, 818-709-1244, x 7123 Chairman and Chief Executive Officer or The Wall Street Group, Inc. Ron Stabiner, 212-888-4848
Source: IRIS International, Inc.
