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Tue, 02/21/2012 - 3:45am
The Associated Press

-- 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(R)ProsVue(TM) 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(R) ProsVue(TM) 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.

-- 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.

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, CEO

IRIS International, Inc.

818-527-7323

-or-

Lynn Pieper, Westwicke Partners

415-202-5678

lynn.pieper@westwicke.com

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