Read Larry Connors' blog – Short Term Trading Strategies
The NADiA(TM) ProsVue(TM) assay will be independently used in this study to assist the Company in furthering the hypothesis that NADiA(TM) ProsVue(TM) can be used to prognosticate post radical prostatectomy patients with low risk of prostate cancer recurrence. As a first priority, IRIS plans to collect its NADiA ProsVue data using real time polymerase chain reaction (RT-PCR) instrumentation that is already cleared for diagnostics use, as required by the FDA. The testing and analysis of 300 patients with serially collected blood samples, retained over an eight year period, is expected to be completed in approximately two months with the results to be incorporated into a FDA 510(k) application, which IRIS expects to submit late in the fourth quarter 2009. Following clearance of this first submission, IRIS plans to re-validate and submit NADiA(TM) ProsVue(TM) for sub-sequent FDA clearances using other RT-PCR systems upon the attainment of FDA clearance by the manufacturers of those devices.
"We are pleased with the initiation of this larger clinical study which follows an earlier 30 patient study, on which we base the prognostic hypothesis for our NADiA(TM) ProsVue(TM) in vitro ultra sensitive diagnostic assay," stated Cesar Garcia, Chairman, President and CEO of IRIS International. "We have already begun to receive the necessary retained patient samples for this larger clinical study. Upon successful conclusion of the experimental analysis, IRIS is planning to submit a 510(k) application with the FDA seeking clearance of a prognostic claim for its NADiA(TM) ProsVue(TM) as an in-vitro diagnostic assay intended to be used in conjunction with clinical evaluation as an aid in predicting risk for prostate cancer recurrence after radical prostatectomy. It is our objective to make our NADiA platform available in as many RT-PCR instruments as possible," he said.
"The results of two prior smaller clinical studies have shown that NADiA(TM) ProsVue(TM) enables the stratification of post-prostatectomy patients, thus supporting a prognostic use that is an enhancement of the intended use proposed in our initial 510(k) submission. We expect the results of this larger study to be consistent with our earlier findings," stated Dr. Thomas Adams, Corporate Vice President and Chief Technology Officer of IRIS. "We believe the ability to identify post-prostatectomy patients with low risk of prostate cancer recurrence would have substantial clinical and economic benefits that should be entitled to significant reimbursement," he added.
In a previously announced retrospective study of stored leftover serum of 85 post-prostatectomy patients, NADiA(TM) ProsVue(TM) detected levels of PSA after radical prostatectomy that were undetectable using conventional ultra sensitive assays. In this study, the NADiA(TM) ProsVue(TM) assay detected a rise of PSA concentration on an average 2-1/2 years before tPSA values reached 100 pg/mL (0.1ng/mL), the sensitivity level of conventional PSA assays.
According to the American Cancer Society there were an estimated 186,320 new cases of prostate cancer in the U.S. in 2008, with 28,660 deaths occurring from prostate cancer in the U.S. alone, making it the second leading cause of cancer death in men. There are currently approximately two million men in the U.S. who have undergone radical prostatectomy with another 155,000 new procedures performed each year.
About IRIS International, Inc.
IRIS International 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 2,300 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 is developing molecular diagnostic tests based on its Nucleic Acid Detection Immunoassay, or NADiA(R), platform, with applications in oncology and infectious disease. For more information 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 in this press release include the timing for completion of the retrospective clinical study; plans to initiate a larger multi-center study, plans to submit NADiA(TM) ProsVue(TM) for FDA clearances using other RT-PCR systems, timing for submission of the FDA 510(k) application, the Company's anticipated claims in its FDA 510(k) application, and the effects of FDA clearance of the Company's claims, including with respect to reimbursement rates, 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 internal R&D initiatives and the clinical study and 510(k) application processes. Other factors and uncertainties that could affect the Company's forward-looking statements include, among other things, unanticipated delays in the commencement and consummation of the retrospective and multi-center clinical studies, unanticipated results from such studies, delays in the 510(k) application process, the timing of submissions and clearances of 510(k) applications for other manufacturers' RT-PCR instruments, and risks related to performance of the RT-PCR instruments upon which NADiA(TM) ProsVue(TM) depends. 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.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: IRIS International, Inc.
CONTACT: IRIS International, Inc. Thomas Adams, Ph.D., Chief Technology Officer 818-709-1244 x 7601 The Wall Street Group, Inc. Ron Stabiner 212-888-4848
More News:
Market Updates |
Stock Alerts |
All Trading News |
Stock Index
About TradingMarkets | Contact | Advertise | Careers | Link to Us | Site Map | Help | Terms & Conditions | Privacy Policy | Return Policy | Testimonials | Feedback
The Connors Group, Inc. ("Company") is not an investment advisory service, nor a registered investment advisor or broker-dealer and does not purport to tell or suggest which securities or currencies customers should buy or sell for themselves. The analysts and employees or affiliates of Company may hold positions in the stocks, currencies or industries discussed here. You understand and acknowledge that there is a very high degree of risk involved in trading securities and/or currencies. The Company, the authors, the publisher, and all affiliates of Company assume no responsibility or liability for your trading and investment results. Factual statements on the Company's website, or in its publications, are made as of the date stated and are subject to change without notice.
It should not be assumed that the methods, techniques, or indicators presented in these products will be profitable or that they will not result in losses. Past results of any individual trader or trading system published by Company are not indicative of future returns by that trader or system, and are not indicative of future returns which be realized by you. In addition, the indicators, strategies, columns, articles and all other features of Company's products (collectively, the "Information") are provided for informational and educational purposes only and should not be construed as investment advice. Examples presented on Company's website are for educational purposes only. Such set-ups are not solicitations of any order to buy or sell. Accordingly, you should not rely solely on the Information in making any investment. Rather, you should use the Information only as a starting point for doing additional independent research in order to allow you to form your own opinion regarding investments. You should always check with your licensed financial advisor and tax advisor to determine the suitability of any investment.
HYPOTHETICAL OR SIMULATED PERFORMANCE RESULTS HAVE CERTAIN INHERENT LIMITATIONS. UNLIKE AN ACTUAL PERFORMANCE RECORD, SIMULATED RESULTS DO NOT REPRESENT ACTUAL TRADING AND MAY NOT BE IMPACTED BY BROKERAGE AND OTHER SLIPPAGE FEES. ALSO, SINCE THE TRADES HAVE NOT ACTUALLY BEEN EXECUTED, THE RESULTS MAY HAVE UNDER- OR OVER-COMPENSATED FOR THE IMPACT, IF ANY, OF CERTAIN MARKET FACTORS, SUCH AS LACK OF LIQUIDITY. SIMULATED TRADING PROGRAMS IN GENERAL ARE ALSO SUBJECT TO THE FACT THAT THEY ARE DESIGNED WITH THE BENEFIT OF HINDSIGHT. NO REPRESENTATION IS BEING MADE THAT ANY ACCOUNT WILL OR IS LIKELY TO ACHIEVE PROFITS OR LOSSES SIMILAR TO THOSE SHOWN.
The Connors Group, Inc.
10 Exchange Place, Suite 1800
Jersey City, NJ 07302
© Copyright 2009 The Connors Group, Inc.
