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IRIS International Announces IRB Approval To Begin The First Stage Of Its NADiA ProsVue Clinical Study

IRIS International, Inc. announced 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 the assay 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. "We are pleased with the initiation of our clinical study in furtherance of discussions we had with FDA as part of Pre-IDE submission for our NADiA ProsVue in vitro diagnostic assay. IRB approval from a leading reputable medical center such as Duke University represents an important milestone clearing the way for IRIS to immediately commence its clinical studies utilizing our NADiA ProsVue ultra sensitive assay," stated César García, Chairman, President and CEO of IRIS International. "As previously stated, we have already identified the necessary retained patient samples for our clinical studies. Upon conclusion of the results, IRIS is planning to submit a new 510(k) application with the FDA seeking clearance of a prognostic claim for its NADiA ProsVue 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," he said. "We believe that our clinical studies will show that NADiA ProsVue enables the stratification of post prostatectomy patients and will support a prognostic use that is an enhancement of the intended use proposed in our initial 510(k) submission. 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," stated Dr. Thomas Adams, Corporate Vice President and Chief Technology Officer of IRIS. In a previously announced retrospective study of stored leftover serum of 85 post-prostatectomy patients, NADiA ProsVue detected levels of PSA after radical prostatectomy that were undetectable using conventional ultra sensitive assays. In this study, the 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.