- FDA cleared test identifies patients with reduced risk for prostate cancer recurrence
- Initial commercial launch underway in the US
CHATSWORTH, Calif., Feb. 21, 2012 (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 testing services today announced that its Iris Personalized Medicine Group has launched its NADiA®ProsVue™ prognostic cancer test in the United States and is accepting blood samples for analysis at its CLIA certified molecular diagnostics laboratory.
The initial domestic launch of NADiA® ProsVue™ is targeting urologists performing a high volume of prostatectomies and key opinion leaders while the company is also pursuing domestic and international partners to accelerate the product adoption. The initial reception from urologists has been favorable and initial patient samples have been received.
The initial launch is underway in the US, after receiving 510(k) clearance from the FDA in September 2011 and CE Mark approval in October 2011. The company is working on a number of peer-review publications that are expected to be published in leading medical and technical journals. In addition, the company will soon initiate a field experience study that will document the impact of the NADiA ProsVue result on clinical decision-making. Results from this study are targeted for publication in 2013.
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NADiA ProsVue is an in-vitro diagnostic assay designed to determine the rate of change of serum total prostate specific antigen (tPSA) over a 10-month period following radical prostatectomy. The test has been indicated for use as a prognostic marker in conjunction with clinical evaluation to help identify patients who are at reduced risk for recurrence of prostate cancer for the eight-year period following prostatectomy.
- NADiA ProsVue is expected to reduce unnecessary treatment of certain post-prostatectomy men thus reducing the morbidity and costs associated with adjuvant treatment such as radiation therapy.
"I am particularly pleased to announce that NADiA ProsVue is now commercially available and we are collecting our first samples in the US," stated Cesar M. Garcia, Chairman, President and Chief Executive Officer of IRIS International. "We received regulatory clearance for the NADiA ProsVue after rigorous validation studies and review, and we are confident this test will be a welcomed addition in the arsenal of prognostic tools available to specialists in identifying prostate cancer patients who are at low risk for clinical recurrence. 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."
A retrospective clinical study of 304 prostate cancer patients evaluated the rate of change among three successive NADiA PSA tests from each patient over a period of at least ten months after a prostatectomy to identify prostate cancer patients with a reduced risk of clinical progression. Recurrence of disease was determined by positive imaging, biopsy results or prostate cancer-related death. Of the patients ProsVue slope identified as having a reduced risk for clinical recurrence, 92.7% showed no signs of clinical recurrence for eight years following a prostatectomy. Similarly, for those whom the test identified as being not at reduced risk, 78% ultimately showed clinical recurrence.
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 3,400 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.
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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.