A fingerprick blood test could diagnose a heart attack in under ten minutes, using a digital system that counts individual troponin molecules. Currently, around half of patients arriving at emergency departments with chest pain receive an inconclusive first troponin test, requiring a second blood draw an hour later. Only about 20% of these patients actually have a heart attack, but the delay in ruling it out ties up beds, staff, and resources. Psyros is developing a point-of-care device that detects troponin at extremely low concentrations from a small fingerstick sample, with an early alert if levels are significantly elevated. This would allow hospitals to use the 0/1-hour algorithm—a modern protocol that can rapidly rule in or rule out heart attacks—at the bedside rather than relying on central lab analysers. If the system gains regulatory approval, emergency departments could triage chest pain patients faster, reducing unnecessary admissions and freeing clinicians to treat those who need them most. The project covers pilot instrument production, a pre-clinical performance study, and the technical documentation required for UKCA and IVDR CE mark approval. A formal clinical validation study will follow separately.
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Research Question: Could a digital approach to immunoassay, based on single-molecule-counting, provide a point-of-care (POC) system that can address all of the requirements for high-sensitivity troponin (hsTn) testing using modern algorithmic approaches? Background: During acute myocardial injury (AMI) the protein cardiac Troponin (cTn) is released into the blood stream. Measurement of cTn in the blood is used to aid in the diagnosis of AMI. Modern algorithmic approaches, such as the 0/1h algorithm incorporate high-sensitivity troponin (hsTn) measurements to rapidly triage patients. An initial test at presentation can instantly rule in or out AMI against defined cut-off levels. However, often the first result is inconclusive (~50%) requiring a follow-up test an hour later to establish the relative change of troponin before a definitive diagnosis can be made. Given that only 20% of patients presenting at the ED with chest pain have a confirmed AMI diagnosis, the more rapidly this can be determined, the better the outcome for patients whilst reducing resource and economic burden for the NHS. Rapid POC hsTn testing would maximise the benefit of the 0/1h algorithm. Systems currently on-market lack performance or are sub-optimal from a useability perspective. Psyros are developing a game-changing, cost-effective, ultrasensitive immunoassay system, compatible with POC settings. Our patented, digital immunoassay method allows detection of individual troponin molecules from a small fingerstick blood sample in under 10 minutes with an early indicator alert if levels are significantly elevated. This will enable greater adoption of 0/1h algorithm and improved resource utilisation. Our aims and objectives for the project: Develop assembly processes and produce pilot instruments and test cartridges for use in a pre-clinical study. Perform a pre-clinical performance study to verify the system performance with fresh patient samples. Selection of a suitable Clinical Research Organization to facilitate our subsequent formal clinical validation performance study required for our regulatory submission (this formal study is not part of this project and will be funded separately) Generation of real-time cartridge shelf-life stability data to support product claims in our regulatory submission ahead of launch Generation of the key technical file documentation required for UKCA/IVDR CE mark approval Definition of key processes required to support the product post-market Timelines: The overall duration of this project is 27 months which reflects the complex nature of the activities to be completed. Anticipated impact and dissemination: We believe the availability of a 0/1h capable bedside test has the potential to truly transform patient care and reduce economic and resource burden usage for the NHS. Project outputs will disseminate to patients via our patient advisory group, to the wider scientific and clinical community through publications and talks at conferences/meetings or hosting a booth. We also intend to disseminate to the wider public through regular press release updates.
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