CHATSWORTH, Calif.--(BUSINESS WIRE)--IRIS INTERNATIONAL, INC. (NASDAQ: IRIS), announced today that it has received Institutional Review Board (IRB) approval from Duke University Medical Center to immediately begin a retrospective clinical study utilizing its NADiA™ ProsVue™ ultra sensitive prostate-specific antigen diagnostic assay. The first stage of the clinical study will use retained serum samples of 30 patients whose prostate cancer relapse, or remission, has been clinically confirmed with imaging data or the patient’s death. The NADiA™ ProsVue™ assay will be independently used in this study to assist the Company in furthering the hypothesis that NADiA™ ProsVue™ can prognosticate patients as low risk of prostate cancer recurrence. The testing of these 30 patient samples is expected to be completed in approximately one month with the results to be incorporated into the Pre-Investigational Device (Pre-IDE) application already reviewed by the FDA. Subsequently, the Company plans to initiate a larger multi-center study which is expected to be completed and submitted with an FDA 510(k) application in the second quarter 2009.
