IRIS International Inc. has announced that its Iris Molecular Diagnostics (IMD) group has successfully completed a retrospective study of stored leftover serum of 85 post-prostatectomy patients, men who had their prostate removed due to prostate cancer, using its investigational NADiA (Nucleic Acid Detection ImmunoAssay) PSA Assay.
In this study, the NADiA PSA Assay detected levels and increasing levels of PSA that were previously undetectable using conventional ultra sensitive assays, thus potentially enabling the detection of biochemical recurrence (BCR) an average 2-1/2 years earlier than with the most sensitive commercially available tPSA assays.
“ We are extremely pleased with the ‘ highly statistically significant ' results of this study and we congratulate our IMD team on this significant accomplishment, which we believe, once these findings are replicated and validated, could become the basis for an algorithm to monitor biochemical recurrence of PSA much earlier than conventional PSA assay. It is also important to note that in the retrospective study, the NADiA PSA clearly separated those patients with and without BCR. Although the regulatory process is going slower than anticipated, we are optimistic that our program will continue to generate data that will support the clearance of strong clinical claims for the NADiA PSA Assay, which should enable us to maximize value and accelerate clinical acceptance, ” said C é sar Garc í a, Chairman, President and Chief Executive Officer of IRIS International, Inc. “ The results of this study have prompted us to review our regulatory strategy as we do not wish to take short cuts at the expense of compromising the potentially high reimbursement for NADiA PSA and other NADiA applications currently in research and development. Discussions with the FDA are in progress, ” he said.
Dr. Thomas H. Adams, Ph.D, Chief Technology Officer and Corporate Vice President, noted that “ We are very satisfied with the progress made with the FDA thus far and this work sets a foundation and a body of knowledge that should help us in future regulatory applications. We are also strengthening our intellectual property and have filed a provisional patent application to protect our new NADiA method. In addition to these highly encouraging results, our team continues to make significant headway on the research and development of our NADiA HIV assay and is on schedule with this project as well. ”
The retrospective study was performed by IMD in collaboration with Dr. Eleftherios P. Diamandis MD, PhD, Head of Clinical Biochemistry at the University of Toronto and Director of Pathology and Laboratory Medicine at Mt. Sinai Hospital in Toronto. Dr. Diamandis currently serves on boards of 25 scientific journals and has published more than 400 original papers. Dr. Diamandis has received numerous awards for his contributions to cancer research including most recently, Investigator of the Year Award from the American Association of Clinical Chemistry and the Morton K. Schwartz Award for Significant Contributions in Cancer Research Diagnostics. He currently serves as a consultant to Iris Molecular Diagnostics.
Collectively, the 85 patient cohort had 435 serial blood samples collected between 100 and 3,200 days after a radical prostatectomy and all 85 men had an initial serum PSA level that could not be detected ( < 100 pg/mL) using a conventional PSA assay. With currently available technology, it is the recommendation of experts that a cut-off point of 200 pg/ml be used as the classifier of biochemical recurrence of prostate disease, according to a recent article published by the Journal of Urology.