Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

The current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the
Banff Classification which represents arbitrary international consensus. Recent data-driven
approaches using molecular and conventional technologies indicate that mere consensus
produces frequently incorrect diagnoses with potential harm to patients due to inappropriate
treatment. To address this unmet need and improve diagnostics in the area of organ
transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC) has developed a new
diagnostic system that combines the molecular and histopathological features of transplant
biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic
System. The present study will validate and refine this system in 500 prospectively
unselected biopsies for clinical indications from American, Canadian and European centres in
addition to 300 biopsies already collected. Due to a considerable interest and support from
participating Centers, the study is further extended to 1200 prospective biopsies. Thus this
is the extension of the INTERCOM study (INTERCOMEX). In addition to demonstrating the
feasibility and value of this System in routine patient care and clinical trials, the study
will develop and optimize a transparent and user-friendly reporting format to communicate
this information to clinicians and obtain detailed feedback on how this system can best
improve patient care.