Organ Quality Assessment (ORQA) - Digital decision-making support tool for point of donation organ assessment

Background The major challenge for NHS organ transplant services identified in its latest strategy document (Organ Transplantation and Donation 2030: Meeting the Need) is transplanting all the organs that are currently donated.

Organ quality assessment is a highly subjective visual skill with no agreed standard scale or assay making the process of audit, education, governance and quality improvement in selecting organs for transplantation highly challenging.

We have developed image analysis algorithms which can take on this role, not only for the NHS, but also other countries.

OrQA™ is a high impact digital health technology package which consists of an online platform and various AI enabled tools to streamline the process of organ donation and transplantation.

The platform is NHS Information Governance approved (DPIA 20-0163) and has the bandwidth to upload, share and analyse organ images in real time from the point of care.

To date we have performed “proof of concept” work in liver, kidney and pancreas transplantation and reached an advanced stage of pre-clinical testing in liver and kidney.

This project is supported and led by individuals from NHS Blood and Transplant (NHSBT), the NIHR Blood and Transplant Research Unit (BTRU) and Quality in Organ Donation (QUOD) biobank as well as a commercial partner Eurofins™ Transplant Genomics Inc.

Aim Deliver OrQA™ software as a photographic organ assessment tool to facilitate efficient organ donation and transplantation. By the end of 24 months this digital product will be ready for a licensing study within the NHS.

Primary Objective Engineer and performance test the OrQA™ device to align with Digital Technology Assessment Criteria for use by NHSBT. Secondary Objectives 2. Validate and embed AI enabled tools within the NHSBT IT structure and QUOD research biobank. 3.

Facilitate the further development of AI models by NIHR BTRU researchers to develop image analysis in pancreas and thoracic transplantation. 4.

Engage with Professionals, Patients and the Public to ensure the safety, acceptability and useability of the digital tools. 5. Deliver a product ready to be licensed by Eurofins™ for worldwide marketing.

Methods The initial phase will involve collection and analysis of around 3000 retrospective kidney and pancreas datasets (0-6 months) obtained from NHSBT databases and 3000 prospective standardised images (6-18 months) facilitated by the QUOD research infrastructure.

Alongside this the team will engage and collaborate with patients and the public, a professional advisory board and IP management group as well as commercial partners to ensure the value proposition.

Anticipated Impact and Dissemination OrQA™ is being developed by NHS associated institutions, using NHS datasets primarily for the benefit of patients in the United Kingdom.

However, the organ assessment tools will be applicable across the globe and particularly attractive to countries with advanced healthcare systems, well developed organ sharing networks and long travel times (North America, Europe and Australasia). These countries represent a potential market estimated to be worth more than $120 billion in 2024.

A key part of this project will be ensuring the technology is effective and competitively priced to meet this market.