CHATSWORTH, Calif., June 6, 2012 (GLOBE NEWSWIRE) -- IRIS International, Inc. (Nasdaq:IRIS), a leading manufacturer of automated in-vitro diagnostics systems and consumables and a provider of high-value personalized diagnostics, today announced that NADiA® ProsVue™ was highlighted in a podium presentation at the 5th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer being held June 6 – 8 in Durham, NC.
NADiA ProsVue slope 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 a radical prostatectomy (RP). The product should not be used for patients whose first serum sample collected more than 6 weeks after RP has a total PSA value greater than 0.1 ng/ml obtained from a standard-of-care PSA assay. The product is not intended for the diagnosis or for the monitoring of prostate cancer.
On Wednesday, June 6, 2012, Dr. Judd W. Moul, MD, Professor and Director of the Duke Prostate Center at Duke University Medical Center, presented additional clinical data from the study conducted for NADiA ProsVue's 510(k) submission and clearance. These data compared the test's prognostic ability for risk stratification of clinical recurrence to surgical margin status.
"Today, surgical margin status is one of the important pathological features utilized in risk stratification of prostate cancer patients post-RP and typically the presence of positive surgical margins is associated with an increased risk of recurrence," stated Judd Moul, MD, Professor and Director of the Duke Prostate Center at Duke University Medical Center. "This study compared the prognostic strength of NADiA ProsVue versus surgical margin status to identify men at a reduced risk of recurrence post-RP. The data showed that of the men with both a NADiA ProsVue slope of less than or equal to 2.0 pg/mL per month and positive surgical margins, 87.7% were stable. The data also showed that of the men with a NADiA ProsVue slope of greater than 2.0 pg/mL per month with positive surgical margins, 78.9% did recur. Consequently, NADiA ProsVue slope was found to be an effective prognostic factor for risk stratification of clinical recurrence and a valuable addition to the physician's armamentarium."
"I am particularly pleased that the benefits and utility of NADiA ProsVue continue to be highlighted in clinical presentations and leading medical journals and publications," stated César M. Garcia, Chairman, President and Chief Executive Officer of IRIS International. "As part of the commercial launch, NADiA ProsVue was recently showcased to a broad audience of urologists at the American Urological Association (AUA) Annual Meeting. Reception from urologists was overwhelmingly positive, and we are confident this test will be a welcomed addition in the arsenal of prognostic tools available to urologists. We believe that this assay will be extremely helpful in identifying low risk patients, thus avoiding unnecessary treatments and their resultant side effects, as well as reducing anxiety for patients and costs to the healthcare system."
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 or a copy of the abstract presented at the conference, 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 is designed to have 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.