Osler Diagnostics collaborates with PHTA to advance point-of-care cardiac testing

Osler Diagnostics has partnered with the University of Birmingham’s Precision Health Technologies Accelerator (PHTA) in Birmingham, UK, to conduct a collaborative usability study that will support the development of the Osler Origin^® System, a novel point-of-care diagnostic platform designed to deliver laboratory-quality cardiac testing directly where patients receive care.

The study, carried out within PHTA’s facilities and involving Clinical Immunology Services (CIS), will evaluate a high-sensitivity troponin I (hs-cTnI) assay intended to aid assessment of suspected acute coronary syndrome, including myocardial infarction (heart attack), and will generate usability evidence for Osler’s broader human factors programme and future regulatory submissions.

As part of Osler’s wider human factors and usability program, the study will generate evidence to support future regulatory submissions. By focusing on how representative healthcare professionals interact with the system and its materials, the collaboration aims to ensure that the Osler Origin platform is suitable for use in real-world emergency and acute care environments.

Human factors and usability assessment in a clinical setting

Within PHTA’s Category 2 laboratory space, participants including nurses, healthcare assistants, emergency medicine clinicians and clinical laboratory professionals will evaluate the Osler Origin System’s training materials, instructions for use and operation. This work will generate usability data from representative end users to support Osler’s ongoing development programme and regulatory strategy.

The study is designed to capture detailed feedback on how healthcare professionals use the system in a regulated environment, helping to inform product design, workflow integration, training approaches and implementation strategies for point-of-care cardiac testing.

Addressing time-critical acute coronary syndrome diagnosis

Acute coronary syndrome, including myocardial infarction, is one of the most time-critical presentations in emergency medicine. Accurate measurement of cardiac troponin concentrations is central to patient assessment and triage in these settings.

High-sensitivity troponin testing is well established in central laboratories, but obtaining results can involve sample transport and laboratory processing steps that may delay decision-making. Point-of-care approaches have the potential to support faster clinical decisions 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 the goal of supporting faster, informed clinical decision-making in urgent and emergency care.

Leveraging CIS and PHTA expertise in immunoassay and diagnostics

Clinical Immunology Services, based at PHTA, brings extensive expertise in immunoassay development, assay validation and clinical laboratory practice through its ISO 15189 UKAS-accredited diagnostic service. This makes CIS well placed to support usability assessment of the Osler Origin System within a regulated environment.

The study will draw on CIS’ experience in translating novel diagnostic technologies into clinical use, while gathering feedback from healthcare professionals that will help shape product design, training materials and implementation strategies. Combined with the broader expertise available across the PHTA ecosystem, this collaboration provides an environment for evaluating how the system may be used in routine clinical 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 program. 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, added, “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.”

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