Roche receives CE mark for chest pain triage algorithm
Roche has announced the CE marking of its innovative Chest Pain Triage algorithm, designed to enhance the detection of Acute Coronary Syndrome (ACS) in emergency departments. Developed in collaboration with Universitätsklinikum Heidelberg, this IVD medical device aims to transform cardiac care by providing standardised assessment tools for clinicians managing chest pain presentations.
Algorithm addresses critical healthcare challenge
Chest pain represents the second highest reason for emergency department visits globally, whilst cardiovascular disease accounts for a third of worldwide deaths. The new algorithm leverages state-of-the-art diagnostic technologies, including high-sensitivity cardiac troponin testing, to help healthcare professionals differentiate between cardiac and non-cardiac chest pain presentations.
“The introduction of our Chest Pain Triage algorithm underscores Roche’s commitment to improving care for cardiovascular disease, one of the world’s largest health burdens,” said Matt Sause, CEO, Roche Diagnostics. “One of the major challenges in managing chest pain in the emergency department is the length of stay, especially since some patients aren’t actually having a heart attack. Our Chest Pain Triage algorithm can help doctors quickly decide who needs urgent cardiac care and who could be discharged sooner. With an early rule-out pathway, we can cut down Emergency Department visit times by over three hours.”
Clinical decision support features
The algorithm provides definitive Rule-In, Rule-Out or Observe recommendations according to European Society of Cardiology (ESC) guidelines. It automatically selects the appropriate ESC 0/1, 0/2, or 0/3 accelerated pathway based on blood sample collection timing, potentially reducing unnecessary hospital admissions and associated costs.
Key features include rapid assessment capabilities for chest pain onset more than three hours before the first blood sample, a medical dossier for clinician support, and simplified documentation allowing doctors to easily copy recommendations and results into patient records.
Integration with existing workflows
The Chest Pain Triage algorithm forms part of Roche’s wider integrated offering to address ACS, incorporating the cardiac troponin T Assay and integration with existing laboratory solutions. This comprehensive approach provides efficient patient triage in emergency settings whilst leveraging ESC guidelines and expertise from leading cardiologists and emergency medicine specialists.
Availability and platform integration
The algorithm is available in Europe, the Middle East, and Asia through Roche’s navify Algorithm Suite, with United States availability planned for a later date. The navify Algorithm Suite represents a cloud-based platform hosting clinical algorithms from Roche and partners, providing laboratories and hospitals with direct workflow integration through Electronic Health Records (EHR) and Lab Information Systems (LIS).
The navify portfolio encompasses more than 30 digital solutions for laboratories, hospitals and patients worldwide, connecting the healthcare community with robust digital infrastructure to integrate data efficiently and accelerate clinician access to innovations and operational insights.
Regulatory status and development
The Chest Pain Triage algorithm has received CE marking as an in-vitro diagnostic (IVD) medical device under the requirements of the IVD regulation (EU) 2017/746 (IVDR). The development represents part of Roche’s commitment to early identification and treatment of cardiovascular disease, with future ACS offerings planned to combine next-generation digital algorithms, biomarkers, near-patient care devices, and laboratory analysers.
Roche’s cardiometabolic portfolio supports faster and more accurate triage decisions, whilst the algorithm can be integrated into current emergency department workflows, subject to specific market and country availability requirements.
- For more information, visit: roche.com
