IRIS International Receives FDA 510(k) Clearance for Its NADiA ProsVue(TM) Prognostic Cancer Test
CHATSWORTH, Calif., Sept. 22, 2011 (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 tests, today announced that it has received 510(k) clearance from the FDA for its NADiA® ProsVue™ prognostic cancer test.
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 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.
The initial ProsVue commercialization strategy will consist of a combination of a targeted direct sales approach through our CLIA laboratory, Arista Molecular, followed by potential collaborations with major laboratories and diagnostic partners.
“We are extremely pleased that the ProsVue test has been cleared for sale in the United States,” stated César M. García, Chairman, President and Chief Executive Officer of IRIS International. “The data from our multi-center clinical study supported our hypothesis that NADiA ProsVue can be useful in identifying post-prostatectomy men with reduced risk of cancer recurrence who may not need further treatment, including radiation therapy. We believe this prognostic assay could help patients avoid unnecessary treatment, reduce morbidity and lower the cost of management and treatment of post radical prostatectomy patients.”
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. NADiA ProsVue is a prognostic prostate cancer marker and is not intended for the diagnosis or for the monitoring of prostate cancer.
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.
“The scientific paper recently presented at the 2011 American Urological Association Annual Meeting cited a multivariate analysis finding NADiA ProsVue to be a significantly better prognosticator of stable post-prostatectomy men than the Gleason score by itself or combined with other pathological indicators presently used to determine which patients do not need follow up treatment,” stated Dr. Thomas Adams, Chief Technology Officer and head of Iris Molecular Diagnostics. “In addition, this regulatory clearance gives us confidence in the capability of our proprietary Nucleic Acid Detection Immunoassay (NADiA) technology to identify extremely low concentrations of proteins that have not been routinely used as a diagnostic or prognostic aid, in the absence of assays with the sensitivity and precision of NADiA. We plan to accelerate our efforts to license the NADiA technology and to develop other assays with significant market opportunities in the field of oncology,” Dr. Adams stated.
“With the recent regulatory clearances of two major product platforms, NADiA ProsVue and our proprietary automated chemistry analyzer, the iChem®VELOCITYTM, we can better focus our resources on the commercialization of NADiA and the development of our next generation platforms in urinalysis and hematology,” Mr. García added.
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 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 3,200 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’s personalized medicine group has a high complexity CLIA-certified laboratory as 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.
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.
CONTACT: Cesar M. Garcia
Chairman and Chief Executive Officer
IRIS International, Inc.
Lynn Pieper, Westwicke Partners