IMD seeks FDA regulatory clearance for NADiA ProsVue prostate cancer prognostic test

IRIS International, Inc. (Nasdaq:IRIS), a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, announced today that its IRIS Molecular Diagnostics (IMD) subsidiary has submitted a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory clearance for NADiA^®ProsVue™, a prostate cancer prognostic test. The test is designed to help physicians identify patients at low risk of cancer recurrence post radical prostatectomy.

The NADiA ProsVue 510(k) filing contains the results of a 300 patient retrospective study using retained patient samples. The Company believes that the study data meets the pre-established primary and secondary endpoints of the study. The results of the NADiA ProsVue prognostic test were compared to clinical endpoints of stable and recurring disease for at least eight years following radical prostatectomy.  The clinical files of 25,000 patients were reviewed to select 611 qualified patients. Three hundred ninety two patients having retained serum samples meeting the study protocol's requirements were statistically selected to generate the 300 patients involved in the study. Two hundred twenty eight patients were classified by the sites as stable and 72 patients were classified as recurring. The specimens used were collected over approximately an 18 month period following radical prostatectomy.

The clinical trial sites included Duke University, Memorial Sloan-Kettering Cancer Center, Eastern Virginia Medical Center, and the University of Washington. The data generated from the retrospective clinical study will be presented at upcoming scientific meetings by the clinical investigators. The study was designed based on the results of a previous 85 patient study (involving 42 and 43 stable and recurrent disease patients, respectively) from Mt. Sinai Hospital in Toronto, Canada and a 31 patient pilot study (involving 16 and 15 stable and recurrent disease patients, respectively) from Duke University. The results of these two previous studies were used, at the suggestion of the FDA following previous submissions, to establish the prognostic indicator algorithm tested in the new study.

"We are pleased with the submission of this 510(k) application for our NADiA ProsVue assay, which represents a major milestone for IRIS International and follows the successful completion of our pivotal retrospective clinical study. We believe FDA clearance of NADiA ProsVue, our first application of our new NADiA product portfolio, will accelerate the adoption of NADiA ProsVue and help us continue our efforts to demonstrate the high clinical utility and value of our NADiA technology for the prognostication of residual cancers and infectious diseases," stated César García, Chairman, President and CEO of IRIS International.

"We believe the high sensitivity of NADiA ProsVue will provide physicians with an important tool in identifying patients with low risk of prostate cancer recurrence for the period following radical prostatectomy, with the potential of reducing unnecessary treatment," stated Dr. Thomas Adams, Corporate Vice President and Chief Technology Officer of IRIS.   "We look forward to the FDA's review of our 510(k) notification and to the potential to offer what we believe is a significant advancement in cancer relapse prognosis, which should lead to better therapeutic outcomes and improved patient care at considerably reduced healthcare costs," he added.

Dr. Robert E. Klem, Vice President of Product Development, said, "We are gratified to reach the completion of this study and, as demonstrated in the FDA filing, with what we believe to be the high quality of the clinical study data. The pre-market notification for NADiA ProsVue is seeking clearance as an in-vitro diagnostic assay with a prognostic claim intended to be used in conjunction with clinical evaluation as an aid in predicting risk for prostate cancer recurrence after radical prostatectomy."

According to the American Cancer Society, in the United States there were an estimated 192,280 new cases of prostate cancer in 2009 with 27,360 deaths, making it the second leading cause of cancer death in men. One in six men will be diagnosed with prostate cancer during his lifetime. Currently, there are more than two million men in the U.S. who have undergone radical prostatectomy with another 85,000 new procedures performed each year.

NADiA ProsVue is the first diagnostic test developed by IMD, formally Leucadia Technologies, which was acquired by IRIS International in April 2006. The Company's platform technology, NADiA (Nucleic Acid Detection Immunoassay), is used for the ultra sensitive detection of proteins. "We believe that analysis of these proteins can be used to help detect signs of cancer and infectious disease. The patented NADiA platform has many possible applications in these areas," Dr. Adams said.