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---------------------------------------------------------------- FOR IMMEDIATE RELEASE

CONTACTS: César García,
Chairman and Chief Executive Officer
818-709-1244
-or-
Ron Stabiner, The Wall Street Group, Inc.
212-888-4848

IN FURTHERANCE OF PRODUCTIVE DISCUSSIONS WITH FDA, IRIS TO PROCEED WITH NEW FDA 510(K) PRE-MARKET NOTIFICATION FOR NADiA™ PSA

Planned Submission Will Include Prognostic Claim; Anticipated Product Introduction Targeted For
First Half Of 2009

CHATSWORTH, CA, July 28, 2008 - IRIS INTERNATIONAL, INC. (NASDAQ: IRIS), after extensive consultation with the US Food and Drug Administration (FDA), intends to resubmit its 510(k) for its NADiA™ PSA (Prostate Specific Antigen) ultra-sensitive diagnostic test with a prognostic claim. Following FDA advice, IRIS has already submitted a request for a Pre-Investigational Device Exemption meeting (Pre-IDE Meeting), an optional process through which the applicant consults with the FDA for the purpose of improving the quality of submissions and to shorten review times. IRIS will submit a new 510(k) seeking clearance of a prognostic claim for identifying post-prostatectomy patients with low-risk of prostate cancer recurrence, with an estimated timeline for anticipated market introduction in the first half of 2009, it was announced today by César García, Chairman, President and CEO of IRIS International.

"We are particularly pleased with our discussions with the FDA. This investigational diagnostic test, we believe, represents a potential major contribution to medicine that will result in improved patient care and comfort at significant healthcare savings," Mr. García stated.

"Following discussions with the FDA regarding the optimal regulatory pathway, we recently submitted a request for a Pre-IDE Meeting with FDA to obtain FDA's feedback on a protocol on a clinical study we are planning which, when concluded, will be used to support the filing of a new 510(k) submission. The new 510(k) submission will seek clearance for a prognostic claim for the NADiA™ PSA as an in-vitro diagnostic assay intended to be used in conjunction with clinical evaluation as an aid in predicting risk for recurrence of prostate cancer after radical prostatectomy. We have maintained continuous communication with the FDA over the last several months, and the pre-IDE meeting should formalize the collaborative review process via written feedback on the protocol and intended use claims from the FDA prior to initiating the study, significantly reducing interpretation risks by either party. We have been notified by the FDA that the Pre-IDE review meeting will be held in August 2008," Mr. García said.

"All of the data submitted in our original 510(k) in February 2007, will be carried-over to the new application. The FDA has already reviewed the analytical performance of our NADiA™ PSA assay and conveyed to us that clearance through the 510(k) process is a viable option depending upon the results of a new clinical study, the protocol of which will be discussed at our scheduled pre-IDE meeting with FDA. We believe that clearance of the prognostic claim in the new submission for NADiA™ PSA would enable the stratification of post-prostatectomy patients and is an enhancement of the claim covered by our initial 510(k) submission. Such a breakthrough in the monitoring of prostrate cancer relapse should result in better therapeutic outcomes and avoiding potentially unnecessary procedures and treatments," added Mr. García.

"IRIS has organized a medical advisory committee consisting of experts in clinical urology, oncology and healthcare reimbursement that are advising the Company about the potential impact of NADiA™ PSA in improved patient treatment and comfort, reduced morbidity and lowered health care costs. Due to these potential benefits, we feel that NADiA™ PSA should command a significantly higher reimbursement," said Dr. Thomas Adams, Corporate Vice President and CTO of IRIS.

In a previously announced retrospective study of stored leftover serum of 85 post-prostatectomy patients the Ultra Sensitive NADiA™ total PSA (tPSA) Assay (BCR) detected levels and increasing levels of PSA after radical prostatectomy that were previously undetectable using conventional ultra sensitive assays. In this study, the NADiA PSA 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. "We believe that if these results are replicated and validated, these findings could become the basis for an algorithm to monitor biochemical recurrence earlier than with most state-of-the-art commercially available sensitive tPSA assays," Dr. Adams said.

ABOUT IRIS INTERNATIONAL
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 urine microscopy systems, with an installed based of more than 1,900 systems in over 50 countries.

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.

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