710223Assays for transplant viabilityClosedGRD Proof of ConceptInnovate UKThis feasibility study aims to develop assay kits for use in operating theatres and clean rooms to determine if donated organs are of sufficient quality for use in transplantation. The demand for donated organs greatly exceeds supply (e.g. 1 donated liver per 3 people on waiting list in USA; 10% on waiting list die each year). A partial solution would be to optimize the utilization of organs harvested from ‘marginal’ donors (e.g. controlled non-heart beating donors), since many of these ‘marginal’ donor organs are currently discarded unused. At present, donated organs are assessed by rating the donor according to a set of criteria (e.g. donor age, cause of death etc.) rather than by assessing the organ itself. Since it is known that patient outcomes are worse with lower quality organs, surgeons err on the side of caution and discard organs from more marginal donors. Accordingly, we are developing a series of rapid and objective quality control (QC) assay kits to reveal the functional quality of donated organs within the timescale and practical constraints of a clinical environment. Our kits aim to (i) increase organ availability by reducing the discard rate; (ii) enable technical staff to avoid wasting resources on non-viable donated organs; (iii) allow newer transplant procedures (e.g. pancreatic islet transplantation) to be optimized through improved in-process monitoring; (iv) enable regulatory compliance by demonstrating the identity, safety and efficacy of transplants before use. Our prototype assays are being developed with inputs from clinicians, biochemists and polymer engineers and have successfully detected reduced tissue viability after tissue storage or re-perfusion injury. Funding will enable our assays to be incorporated into an ongoing study (organized by UK and USA based transplant surgeons) that is comparing the viability of pancreas, islet and liver samples that have been manipulated using ‘gold-standard clinical’ and ‘novel’ methods.