- Test Identifies Patients at Reduced Risk for Prostate Cancer Clinical Recurrence After Surgery
CHATSWORTH, Calif., May 21, 2012 (GLOBE NEWSWIRE) -- IRIS International, Inc. (Nasdaq:IRIS), a leading manufacturer of automated in-vitro diagnostics systems and consumables, today announced that the Iris Personalized Medicine group is unveiling its novel prostate cancer system, NADiA® ProsVue™ at the American Urological Association (AUA) Annual Meeting in Atlanta. NADiA ProsVue, a prognostic prostate cancer test, will be showcased at the Iris Personalized Medicine booth #2530 where urologists and healthcare professionals can learn more about the test's innovative Immuno-PCR technology and clinical benefit.
The commercial domestic launch of NADiA ProsVue is underway after having received 510(k) clearance from the FDA and CE Mark approval in the fall of 2011. The company continues to work on a number of peer-reviewed publications and recently had a paper published in Clinical Chemistry, including data on NADiA ProsVue assay sensitivity, precision and reproducibility. Additional data will be presented at the upcoming 5th International Symposium on Focal Therapy and Imaging in Prostate & Kidney Cancer June 6-8, 2012 in Durham, that demonstrates NADiA ProsVue's superior ability to identify men at reduced risk for clinical recurrence compared to surgical margin data.
"We are pleased that NADiA ProsVue is being showcased to a broad audience of urologists from around the world," said César M. García, Chairman, President and Chief Executive Officer of IRIS International. "In addition, we recently initiated our Field Experience Trial (FET) which is designed to show how NADiA ProsVue impacts clinical decision-making and potentially optimizes healthcare costs while reducing patient morbidity from unnecessary adjuvant treatment post-radical prostatectomy. The FET is gaining significant interest with enrollment from both leading academic institutions as well as private urology practices."
"NADiA ProsVue could mark a significant change in the way we care for and manage prostate cancer patients," stated Judd Moul, MD, Professor and Director of the Duke Prostate Center at Duke University Medical Center. "Many men who may not be at a high risk for clinical recurrences currently receive adjuvant therapy after surgery, which often leads to complications such as impotence and incontinence. NADiA ProsVue results provide clinicians with an important new tool to help determine those patients that may not benefit from additional therapy and can avoid the effects of unnecessary treatment."
NADiA ProsVue is an in-vitro diagnostic assay for determining rate of change of serum total prostate specific antigen (tPSA) over a period of time. A retrospective clinical study of 304 patients evaluated the slope of three successive ProsVue tests over a period of at least ten months after a prostatectomy to identify prostate cancer patients with no evidence of disease or clinical progression. Recurrence of disease was determined by positive imaging, biopsy results or prostate cancer related death.
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%. Consequently, 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.
NADiA ProsVue is available through Iris Personalized Medicine's high complexity CLIA-certified laboratory. For more information on NADiA ProsVue, please visit www.irispermed.com.
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 3,700 systems in more than 50 countries. The Company is expanding its core imaging and morphology expertise into related markets, including applications in hematology and body fluids. In addition, the Company's personalized medicine group has a high complexity CLIA-certified laboratory for the further development and commercialization of 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.