Enhanced Rapid Assay for Monitoring Immunosuppressant Drugs in Whole Blood

Frequent monitoring of tacrolimus (TAC), a mainstay immunosuppressant drug, 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. A point of care device for the testing of tacrolimus will greatly enhance the quality of life and patient care for transplant patients by enabling quick medication dosage adjustments by healthcare providers for more personalized medicine that results in reduced organ rejection and patient toxicity. Intelligent Optical Systems, Inc. (IOS) has successfully developed, bench-tested, and validated, preclinically and clinically, a functional rapid test prototype for monitoring TAC in fingerstick/venous whole blood. The assay was calibrated for fully quantifying TAC at a clinically relevant range of 0-20 ng/mL, from 5-10 uL of EDTA whole blood within 20 min., enabling point of care testing. We have filed a patent for the technology (PCT/US2022/046124). Discussions with the FDA via the Pre-Submission process to determine the regulatory pathway for the final product indicate a clear path for 510(k) pre-market notification and lists critical considerations for obtaining FDA approval for CLIA waived and at-home use. The results of the Phase II work brought the TAC rapid test to a TLR 6. In the proposed Sequential Phase II work, we will further mature and commercialize this clinically proven rapid assay through final product validation, obtaining FDA 510(k) premarket notification approval, planning for commercial manufacturing, and preparing for CLIA waiver approval. We will take a multidisciplinary teaming approach to integrate the most recent FDA-approved technologies into the final product and to quickly make the product available for the end user. This includes (i) teaming with a world-leading in vitro diagnostic reader manufacturer to adapt an FDA-approved reader platform, (ii) using an FDA-approved fingerstick collection kit, (iii) implementing a Quality Management System (QMS) for the manufacturing test material, and (iv) working with a network of clinical partners in the U.S. on the 510(k) application, which will help streamline the approval process. Additionally, with our network of established clinical partners who are experts in transplantation and clinical laboratory diagnostics, we will plan the study for obtaining FDA approval for CLIA-waived and at-home uses for the product in Phase III, making it available for transplant recipients in point of care settings. By the end of the Sequential Phase II, we expect to reach TRL 7-8 for this product.