CHATSWORTH, Calif., Oct. 26, 2011 (GLOBE NEWSWIRE) -- IRIS International, Inc. (Nasdaq:IRIS), a leading manufacturer of automated in-vitro diagnostics systems and consumables, and a developer of high-value personalized diagnostics tests, today announced that its IRIS Molecular Diagnostics subsidiary has received ISO 13485:2003 certification and Conformité Européenne (CE) Mark for its NADiA® ProsVue™ prognostic cancer test.
"We are delighted to have achieved this milestone, allowing for NADiA ProsVue to be marketed in the European Union and other countries that recognize the CE Mark. Consistent with our US strategy, we are pursuing collaborations with major laboratories and diagnostic partners to commence commercializing ProsVue in these markets in 2012," stated César M. García, Chairman, President and Chief Executive Officer of IRIS International. "As a predictive indicator, ProsVue can be useful to identify patients with low risk of cancer recurrence post-prostatectomy and help avoid unnecessary treatment reducing the morbidity and costs associated with adjuvant treatment, such as radiation therapy."
NADiA ProsVue determines the rate of change of serum total prostate specific antigen (tPSA) and is indicated for use as a prognostic marker in conjunction with clinical evaluation as an aid in identifying those patients at reduced risk for recurrence of prostate cancer for the eight year period following prostatectomy. Data from a retrospective clinical study of 304 patients included in the CE filing demonstrated that a ProsVue slope of equal to or less than 2.0 pg/mL per month in the first year following radical post-prostatectomy was highly associated with no evidence of disease over the long-term follow up. The study resulted in a negative predictive value (NPV), or the proportion of patients correctly identified as stable, of 92.7% and a positive predictive value (PPV), or proportion of patients correctly identified as recurring, of 78.0%.
The CE Mark approval certifies the product meets European safety, health and quality requirements. NADiA ProsVue received 510(k) clearance from the FDA in September 2011.
About the NADiA Technology Platform
NADiA® technology, Nucleic Acid Detection Immunoassay, is a molecular diagnostics platform targeting the early detection of proteins associated with cancer and infectious diseases utilizing a novel ultra-sensitive and precise method. NADiA combines immunoassay and real-time Polymerase Chain Reaction (PCR) methodologies, or Immuno-PCR, with the potential to detect proteins with femtogram/milliliter sensitivity (10-15 gram/milliliter). As NADiA has the ability to effectively measure extremely low concentrations of proteins, which may be under the detection threshold of current immunoassay methods, it has the potential to provide better therapeutic outcomes for patients.
About IRIS International, Inc.
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 3,200 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 body fluids. In addition, the Company's personalized medicine group has a high complexity CLIA-certified laboratory as 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.