CHATSWORTH, Calif., May 23, 2011 (GLOBE NEWSWIRE) -- IRIS International, Inc. (Nasdaq:IRIS), announced today that a poster of the results of a multi-center clinical study utilizing its proprietary NADiA® ProsVue™ prognostic prostate cancer test in 304 post-radical prostatectomy patients, was presented last week at the American Urological Association (AUA) 2011 Annual Meeting in Washington, DC by principal study investigator and lead author, Judd W. Moul, MD, Director of the Prostate Cancer Center and the Division Chief of Urology at Duke University Medical Center. The Company also announced the submission of an accelerated sample stability study requested by the FDA as part of IRIS's reply to an "Additional Information" letter received from the FDA in March 2011.
The study evaluated 304 patients treated at four clinical sites and followed for up to 17.6 years for clinical recurrence post-radical prostatectomy. Candidates were required to have an initial prostate specific antigen (PSA) level below 0.1 ng/mL (100 picogram per milliliter), which is below the current limit of detection of most FDA cleared assays. Results of IRIS's proprietary ultra-sensitive NADiA ProsVue test were compared with the outcome of documented clinical recurrence following radical prostatectomy. The ProsVue test was able to quantify PSA levels in all patient samples. The clinical study demonstrated that patients with a ProsVue linear slope of less than or equal to 2.0 pg/mL per month within the first year following radical prostatectomy are at greatly reduced risk of prostate cancer recurrence and was highly associated with no evidence of disease in up to 17.6 years of follow-up.
The linear rate of change (slope) of ProsVue PSA in picogram per milliliter (pg/mL) per month post-radical prostatectomy was calculated for each patient using three successive PSA values determined from banked serum samples. A pre-specified cut point of 2.0 pg/mL per month was used to divide patients into two groups as "at reduced risk for recurrence" or "not at reduced risk for recurrence." This binary expression of the variable was compared to the reference clinical categorization of each patient as either exhibiting stable disease or clinical recurrence. The NADiA ProsVue test was compared with traditional risk factors (pre-surgery PSA level, pathologic stage and Gleason score) using univariate and multivariate Cox proportional hazards regression and Kaplan-Meier analysis.
In univariate analysis a ProsVue slope greater than 2.0 pg/mL/month showed a hazard ratio of 18.3, which represents a 94.5% reduction in risk of recurrence for patients with a slope of less than or equal to 2.0 pg/mL per month. In the presence of the traditional risk factors, multivariate analysis showed a hazard ratio for ProsVue slope of 9.8, representing an 89.8% reduction in risk of recurrence for patients with ProsVue slope below the cut point of 2.0 pg/mL per month. Of the traditional factors, only the pathologic Gleason score was a significant predictor with a hazard ratio of 5.4, or an 81.4% reduction in risk for patients with a Gleason score of less than or equal to 6.
In presenting the poster, Dr. Moul noted that clinical management following radical prostatectomy (RP) necessarily involves individualized programs based on risk for recurrence. Predictive factors often utilized include pre-RP serum PSA, Gleason score, and various pathological tumor characteristics. However, these traditional factors do not generally display strong predictive significance, even when used in combination. Thus, new tools for risk stratification are required for estimating survival, determining if secondary therapies are needed and defining intensity of follow-up. The ProsVue assay was investigated in a multicenter statistically powered regulatory clinical trial as a new risk stratification method.
The poster titled, "PSA Slope Identifies Men at Reduced Risk for Prostate Cancer Recurrence Post- Radical Prostatectomy: A Multi center Study of the NADiA® ProsVue™ Assay," can be found on the following websites and .
César García, Chairman, President and CEO of IRIS International, said, "This is the first study to correlate clinically documented recurrence with the results of the NADiA ultrasensitive PSA test and stable disease over prolonged follow-up. We believe the data supports our hypothesis that NADiA ProsVue can contribute useful information as a prognostic indicator in identifying post-prostatectomy patients with low risk of cancer recurrence. Any predictive diagnostic which could avoid unnecessary treatment will prove helpful to patients, the medical community and the healthcare system. I am also pleased to report that we have replied to the Additional Information letter received from the FDA in March 2011, including the submission of an accelerated sample stability study requested by the FDA. At this point in time, we have submitted all the information requested by this agency and we have scheduled a conference with FDA officials to discuss our submission."
Dr. Thomas Adams, Ph.D., IRIS Chief Technology Officer, added, "Compared with Gleason score and traditional factors in the multivariate analysis, ProsVue slope was the strongest independent predictor in the model. Due to its high sensitivity, we believe NADiA ProsVue provides information previously unknown in post-radical prostatectomy patients. Potential clinical utility may include identification of patients not requiring long-term oncologic treatment, or a lack of need for adjuvant radiation therapy, a high cost procedure associated with significant morbidity."
The study was led by Duke University Medical Center, Durham, NC; Memorial Sloan-Kettering Cancer Center, New York, NY; Eastern Virginia Medical School, Norfolk, VA; and the University of Washington Medical Center, Seattle, WA. Principal investigator for the study and the first author is Judd W. Moul, MD, Director of the Prostate Cancer Center at Duke University Medical Center and the Division Chief of Urology. Dr. Moul has published more than 500 medical and scientific manuscripts and book chapters and has lectured at national and international meetings. The other study authors include Oliver John Semmes, PhD, Professor of Microbiology & Molecular Cell Biology, Eastern Virginia Medical School; Robert Vessella, PhD, Department of Urology, University of Washington; Hans Lilja, MD, PhD, Memorial Sloan-Kettering Cancer Center; Mark Sarno and Melissa Triebell, from Iris Molecular Diagnostics.
The three frozen serum samples were collected 1.5 to 19.4 months following radical prostatectomy with the first sample required to have a PSA concentration less than 100 pg/mL as determined using a standard PSA monitoring assay. Recurrence of disease was determined by positive imaging, biopsy results or prostate cancer related death. The median follow-up was 11 years in stable patients and 4.7 years in clinically recurring patients.
The NADiA® technology is a molecular diagnostics platform targeting the early detection of relapse of cancer and infectious diseases utilizing a novel ultra-sensitive and precise method for the detection of proteins. It is capable of performing these assays using real-time Polymerase Chain Reaction (PCR) systems to effectively measure extremely low concentrations of proteins, which are under the detection threshold of current immunoassay methods.
The ProsVue test is pending FDA 510(k) clearance and the permissible claims and product launch in the US depend on the terms and timing of any clearance. It is contemplated that IRIS's CLIA-certified molecular diagnostics laboratory, Arista Molecular, will be the exclusive ProsVue provider upon attainment of FDA clearance.
According to the American Cancer Society, there were an estimated 217,730 new cases of prostate cancer in the U.S. in 2010 with 32,050 deaths, making it the second leading cause of cancer deaths in men. Currently, there are more than 2,000,000 men in the US who have undergone radical prostatectomy with another 85,000 new procedures performed each year.
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 3,100 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 recently acquired a high complexity CLIA-certified molecular pathology laboratory offering differentiated, high value molecular diagnostic services in the rapidly growing field of personalized medicine. The laboratory provides 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 .
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CONTACT: Cesar Garcia, Chairman and Chief Executive Officer IRIS International, Inc. 818-527-7000 or- Ron Stabiner, The Wall Street Group, Inc. 212-888-4848