An innovative universal point-of-care diagnostic platform delivering cost-effective, high-sensitivity and multiplexed testing targeting rapid detection and diagnosis of sepsis

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Sepsis, a dysregulated immune response to infection leading to organ failure, is the leading cause of preventable death in the UK. Annually there are ~250,000 sepsis cases resulting in 46,000 deaths at a cost of ~£1.5Bn to the NHS and ~£11Bn to the UK economy.Early detection and treatment of sepsis significantly improves patient outcomes, with \>50% reduction in mortality and morbidity if treated within 1 hour of hospital admission.Procalcitonin 'PCT', realised during organ necrosis, is the leading clinically validated biomarker for sepsis. PCT is frequently tested in combination with biomarkers such as C-reactive protein 'CRP' (inflammation) to provide a putative diagnosis.For reliable detection/diagnosis, PCT assays require high-sensitivity measurement within the hospital laboratory. Such tests are slow, delaying access to urgent care. Currently \>37% of sepsis patients do not receive treatment within 1hr resulting in 14,000 preventable deaths.Whilst some devices exist enabling rapid (<15 minutes) PCT testing at point-of-care (PoC), these devices fail to deliver laboratory quality measurements thereby limiting clinical usefulness.These devices are also restricted to only a handful of biomarkers with limited multiplexing capacity (restricting follow-up/alternative testing) and are expensive.Osler seek to overcome these challenges through development of the world's first universal PoC diagnostic platform delivering real-time, high sensitivity, high multiplexed and cost-efficient testing for any of the majority of clinical biomarkers from a single drop of blood. The platform is enabled through a portfolio of advanced electroanalytical techniques.The project will further develop and demonstrate the platform for rapid high-sensitivity measurement of PCT and CRP.Key areas of focus include PCT assay development, biosensor development incorporating the PCT and CRP assays, development of the PCT/CRP test cartridge, integration of the novel test cartridge with Osler's existing measurement instrument, and demonstration of performance in comparison with conventional laboratory testing using patient blood samples.The global market for sepsis diagnostics is forecast to reach £742M by 2025 at a CAGR of 9.8%.