LDx-RPOC Investigating the potential of rapid diagnostic technology in point-of-care

Linear Diagnostics Limited(LDL), in partnership with NIHR HealthTech Research Centre (HRC) in Diagnostic and Technology Evaluation and the North East Innovation Lab (NEIL) is developing a portable, low-cost, accurate point-of-care diagnostic platform, LDx-RPOC, capable of identifying infections, in a single sample, faster than any commercially available alternative. Proof of concept work to date has shown successful results for LDL s technologies, providing a fast, accurate diagnostic tests for CT, NG, Covid-19 and UTIs. Traditional Nucleic Acid Amplification Test (NAAT) based diagnostics require a long time to result, specific trained expertise, and are expensive. Results can take days/weeks and the process is not conducive to patient wellbeing or effective treatment outcomes. The World Health Organisation (WHO) stipulates tests should be easy to use with minimal training, and results obtained quickly (<20 min), to minimize loss to patient follow up. Existing technologies have been unable to meet this <20 min target and rely on trained staff. Linear Diagnostics have developed a suite of technologies for rapid sensing of infections, primarily urological, that are ideally suited to employment in a point-of-care device which can be deployed in both primary health locations (e.g. community health clinics, care homes) and also specialised diagnostic locations (e.g. pharmacies, diagnostic walk-in centres). The HRC will work to identify the best focus for LDL based on a detailed study of health economics (Year 1&3) and patient need (Year 1). LDL work will include finalising the integration of a cartridge and reader design platform (Year 1), validation of the platform (Year 2) and a clinical evaluation of patient samples (Year 3) with commercialisation, IP, and marketing work conducted in parallel. This will be the first test of LDx-RPOC on clinical samples in a real-world setting (TRL4). We have currently performed testing to TRL3 where we have tested the technologies on the bench and in part on prototype devices. We have carried out fast DNA/RNA amplification on patient clinical samples using benchtop PCR type devices or detected bacterial standards using out 1st generation prototype but will be aiming in this project to integrate the processes. Once completed we expect to bring the project to TRL5 and be ready for full patient trials