- Test seeks to identify post-prostatectomy patients with low risk of cancer recurrence
- Candidates initial post-radical PSA levels had to be less than 100 pg/mL, below the current limit of detection of most FDA cleared assays
CHATSWORTH, Calif., Feb. 17, 2011 (GLOBE NEWSWIRE) -- IRIS International, Inc. (Nasdaq:IRIS), at the American Society for Clinical Oncology (ASCO) 2011 Genitourinary Cancers Symposium in Orlando, FL, today presented an abstract of the results of a multi-center clinical study utilizing its proprietary NADiA®ProsVue™ prognostic prostate cancer test in 392 post-radical prostatectomy patients with PSA levels below 100 pg/mL (picogram per milliliter). In the clinical study, IRIS's proprietary ultra-sensitive NADiA ProsVue prostate cancer test was able to quantify PSA levels in all patient samples, with an initial median value for stable patients of 2.7 pg/mL, undetectable by the most sensitive FDA cleared assays currently available.
The study evaluated the slope of three successive ProsVue™ tests after a prostatectomy to identify prostate cancer patients with no evidence of disease or clinical progression. The clinical hypothesis under test was that patients with a calculated ProsVue slope equal to or less than 2.0 pg/mL per month have low risk of cancer recurrence. Utilizing this slope threshold, the calculated sensitivity and specificity was 75.0% and 96.6%, respectively, indicating 96.6% of all stable patients were accurately identified. The positive predictive value (PPV), or proportion of patients correctly identified as recurring, was 81.4%, and the negative predictive value (NPV), or the proportion of patients correctly identified as stable, was 95.2%. 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 Abstract #72511 titled, "Prognostic Impact of Post-Prostatectomy PSA Slope Determined With a Novel, Nucleic Acid Detection Immunoassay (NADiA ProsVue) for Total PSA," can be found on the following websites www.proiris.com/abstract and www.aristamolecular.com.
"We are very pleased with the preliminary data from our multi-center retrospective study, supporting our hypothesis that NADiA ProsVue can contribute useful information as a prognostic indicator in identifying post-prostatectomy patients with low risk of cancer recurrence," stated Cesar Garcia, Chairman, President and CEO of IRIS International. "Any predictive diagnostic which could avoid unnecessary treatment will prove helpful to patients, the medical community and the healthcare system."
Dr. Thomas Adams, Ph.D., IRIS Chief Technology Officer, added, "Due to NADiA technology's high sensitivity, we believe NADiA ProsVue provides information previously unknown in post-radical prostatectomy patients. Potential clinical utility may include patients not requiring long-term oncologic treatment, or the need for adjuvant radiation therapy, a high cost procedure associated with significant morbidity."
The study was led by Duke University Medical Center, Memorial Sloan-Kettering Cancer Center, Eastern Virginia Medical School and the University of Washington Medical Center. 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, Ph.D., Professor of Microbiology & Molecular Cell Biology, Eastern Virginia Medical School, Robert Vessella, Ph.D., Department of Urology, University of Washington, Hans Lilja, MD., Ph.D., Memorial Sloan-Kettering Cancer Center, and Jonathan E. McDermed, Pharm.D., Iris Molecular Diagnostics.
All patients selected for the study needed to have an initial PSA concentration less than 100 pg/mL, below the current limit of detection of most FDA cleared assays. The three frozen serum samples were collected 1.5 to 19.4 months following radical prostatectomy. Recurrence of disease was determined by positive imaging, biopsy results or prostate cancer related death. The median follow-up was 10.5 years, with stable patients being followed for at least eight years.
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 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 3,000 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 urinary tract infections. 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 www.proiris.com.
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