Osler Diagnostics has partnered with the University of Birmingham’s Precision Health Technologies Accelerator (PHTA) to support the development of its Osler Origin® System, a novel diagnostic platform designed to deliver laboratory-quality testing directly at the location where patients receive care.
The collaborative usability study will see Osler work with PHTA and its anchor resident, Clinical Immunology Services (CIS), to evaluate the Osler Origin’s high-sensitivity troponin I (hs-cTnI) assay, which is being developed to support the assessment of suspected acute coronary syndrome, including myocardial infarction (heart attack). The study forms part of Osler’s broader human factors and usability programme and will generate evidence to support future regulatory submissions.
Within PHTA’s state-of-the-art Category 2 laboratory space, participants including nurses, healthcare assistants, emergency medicine clinicians and clinical laboratory professionals will assess the system’s training materials, instructions for use and operation; generating usability data from representative healthcare professionals to support Osler’s ongoing development programme and future regulatory submissions.
Acute coronary syndrome, including myocardial infarction, is one of the most time-critical presentations in emergency medicine, and accurate measurement of cardiac troponin concentrations is central to patient assessment and triage. While high-sensitivity troponin testing is well established in central laboratories, obtaining results can involve sample transport and laboratory processing steps. Point-of-care approaches have the potential to support faster clinical decision-making by enabling testing nearer to the patient. The Osler Origin® System is being developed to deliver high-sensitivity troponin I measurement at the point of care while maintaining laboratory-quality analytical performance.
With extensive expertise in immunoassay development, assay validation and clinical laboratory practice through its ISO 15189 UKAS-accredited diagnostic service at PHTA, CIS is ideally placed to support usability assessment within a regulated environment. The study will draw on CIS’s experience in translating novel diagnostic technologies into clinical use, while gathering feedback from healthcare professionals that will help inform product design, training and implementation strategies. Combined with the broader expertise available across the PHTA ecosystem, this provides an ideal environment for evaluating how the system may be used in routine care.
John Sperzel, Chief Executive Officer of Osler Diagnostics, said: “PHTA offers the perfect combination of laboratory facilities, clinical expertise and access to representative end users, to help us advance this important stage of our programme. Insights from healthcare professionals working in urgent and emergency care settings will be invaluable as we prepare to launch the Osler Origin® to support faster clinical decision-making when time matters most.”
Professor Gino Martini, Chief Executive Officer at PHTA, said: “Osler’s presence at PHTA exemplifies the kind of translational activity our facility is designed to support – bringing an innovative diagnostics company into the heart of a thriving clinical-academic ecosystem to collaborate and innovate. Osler’s technology has genuine potential to improve decision-making in time-critical emergency care, and by bringing together specialist laboratory infrastructure, clinical insight and access to relevant end users, we are proud to help support that journey.”
Professor Alex Richter, Director of CIS, said: “Clinical Immunology Services at PHTA bridges the gap between laboratory science and clinical application. Supporting the usability evaluation of a novel point-of-care cardiac assay, with real-world A&E and laboratory end users, is a natural and important extension of that mission.”
