Enhanced Rapid Assay for Monitoring Immunosuppressant Drugs in Plasma

Frequent monitoring of immunosuppressant drugs in vascularized composite allotransplantation (VCA) is necessary to avoid transplant rejection and drug toxicity. This is mainly attributed to the short therapeutic window and the differences in pharmacokinetics and pharmacodynamics between individuals. Intelligent Optical Systems, Inc. (IOS) proposes to adapt its advanced rapid assay technology so that a simple finger stick assay can detect tacrolimus (FK506) in whole blood. The proposed development will benefit from a multidisciplinary approach that includes: advances in rapid assay technology developed by IOS, collaboration with established VCA researchers for the in-vivo animal model studies, collaboration with recognized clinical experts for validation of the platform in human subject studies, and product manufacturing and marketing guidance from a leader in finger stick-based diagnostics, enabling us to achieve an expected TRL of 6 or above at the end of Phase II.