Roche receives CE Mark for its Chest Pain Triage algorithm to enhance detection of Acute Coronary Syndrome (ACS)
Roche (RHHBY) has received CE Mark approval for its innovative Chest Pain Triage algorithm, developed in collaboration with Universitätsklinikum Heidelberg. The algorithm, part of the navify® Algorithm Suite, aims to enhance the detection of Acute Coronary Syndrome (ACS) in emergency departments.
The technology leverages high-sensitivity cardiac troponin testing and European Society of Cardiology (ESC) guidelines to help differentiate between cardiac and non-cardiac chest pain. According to Roche Diagnostics CEO Matt Sause, the algorithm can reduce Emergency Department visit times by over three hours through an early rule-out pathway.
The algorithm provides Rule-In, Rule-Out, or Observe recommendations and automatically selects the proper ESC pathway based on blood sample timing. Currently available in Europe, the Middle East, and Asia, with future US availability planned, the system integrates with existing emergency department workflows through Electronic Health Records and Lab Information Systems.
Roche (RHHBY) ha ottenuto l'approvazione CE per il suo innovativo algoritmo di triage per il dolore toracico, sviluppato in collaborazione con l'Universitätsklinikum Heidelberg. L'algoritmo, parte della navify® Algorithm Suite, mira a migliorare la rilevazione della Sindrome Coronarica Acuta (ACS) nei reparti di emergenza.
La tecnologia sfrutta il test della troponina cardiaca ad alta sensibilità e le linee guida della European Society of Cardiology (ESC) per distinguere tra dolore toracico di origine cardiaca e non cardiaca. Secondo Matt Sause, CEO di Roche Diagnostics, l'algoritmo può ridurre i tempi di visita in pronto soccorso di oltre tre ore grazie a un percorso di esclusione precoce.
L'algoritmo fornisce raccomandazioni di Rule-In, Rule-Out o di osservazione e seleziona automaticamente il percorso ESC adeguato in base al momento del prelievo ematico. Attualmente disponibile in Europa, Medio Oriente e Asia, con una futura disponibilità negli Stati Uniti, il sistema si integra con i flussi di lavoro dei reparti di emergenza tramite cartelle cliniche elettroniche e sistemi informativi di laboratorio.
Roche (RHHBY) ha recibido la aprobación del marcado CE para su innovador algoritmo de triaje para el dolor torácico, desarrollado en colaboración con el Universitätsklinikum Heidelberg. El algoritmo, parte de la suite navify® Algorithm Suite, tiene como objetivo mejorar la detección del Síndrome Coronario Agudo (SCA) en los servicios de urgencias.
La tecnología aprovecha la prueba de troponina cardíaca de alta sensibilidad y las guías de la Sociedad Europea de Cardiología (ESC) para ayudar a diferenciar entre dolor torácico cardíaco y no cardíaco. Según Matt Sause, CEO de Roche Diagnostics, el algoritmo puede reducir el tiempo de visita en urgencias en más de tres horas mediante una vía temprana de descarte.
El algoritmo ofrece recomendaciones de Rule-In, Rule-Out u Observación y selecciona automáticamente la vía ESC adecuada según el momento de la toma de muestra sanguínea. Actualmente disponible en Europa, Medio Oriente y Asia, con planes de lanzamiento en EE. UU., el sistema se integra con los flujos de trabajo existentes en urgencias a través de registros electrónicos de salud y sistemas de información de laboratorio.
로슈(RHHBY)는 하이델베르크 대학병원(Universitätsklinikum Heidelberg)과 협력하여 개발한 혁신적인 흉통 분류 알고리즘에 대해 CE 인증을 획득했습니다. 이 알고리즘은 navify® Algorithm Suite의 일부로, 응급실에서 급성 관상동맥 증후군(ACS) 진단을 향상시키는 것을 목표로 합니다.
이 기술은 고감도 심장 트로포닌 검사와 유럽 심장학회(ESC) 지침을 활용하여 심장성 흉통과 비심장성 흉통을 구분하는 데 도움을 줍니다. 로슈 다이아그노스틱스의 CEO 매트 소스(Matt Sause)에 따르면, 이 알고리즘은 조기 배제 경로를 통해 응급실 체류 시간을 3시간 이상 단축할 수 있습니다.
이 알고리즘은 Rule-In, Rule-Out 또는 관찰 권고를 제공하며, 혈액 샘플 채취 시점에 따라 적절한 ESC 경로를 자동으로 선택합니다. 현재 유럽, 중동, 아시아에서 사용 가능하며, 향후 미국 출시도 예정되어 있으며, 전자의무기록(EHR)과 실험실 정보 시스템(LIS)을 통해 기존 응급실 업무 흐름과 통합됩니다.
Roche (RHHBY) a obtenu l'approbation du marquage CE pour son innovant algorithme de triage de la douleur thoracique, développé en collaboration avec l'Universitätsklinikum Heidelberg. Cet algorithme, faisant partie de la suite navify® Algorithm Suite, vise à améliorer la détection du syndrome coronarien aigu (SCA) dans les services d'urgence.
La technologie utilise le test de troponine cardiaque à haute sensibilité et les recommandations de la Société Européenne de Cardiologie (ESC) pour aider à différencier la douleur thoracique d'origine cardiaque de celle d'origine non cardiaque. Selon Matt Sause, PDG de Roche Diagnostics, l'algorithme peut réduire le temps de visite aux urgences de plus de trois heures grâce à un parcours d'exclusion précoce.
L'algorithme fournit des recommandations Rule-In, Rule-Out ou d'observation et sélectionne automatiquement la voie ESC appropriée en fonction du moment du prélèvement sanguin. Actuellement disponible en Europe, au Moyen-Orient et en Asie, avec une disponibilité future prévue aux États-Unis, le système s'intègre aux flux de travail existants des urgences via les dossiers médicaux électroniques et les systèmes d'information de laboratoire.
Roche (RHHBY) hat die CE-Kennzeichnung für seinen innovativen Chest Pain Triage Algorithmus erhalten, der in Zusammenarbeit mit dem Universitätsklinikum Heidelberg entwickelt wurde. Der Algorithmus, Teil der navify® Algorithm Suite, soll die Erkennung des Akuten Koronarsyndroms (ACS) in Notaufnahmen verbessern.
Die Technologie nutzt hochsensitive kardiale Troponin-Tests und die Leitlinien der European Society of Cardiology (ESC), um zwischen kardialem und nicht-kardialem Brustschmerz zu unterscheiden. Laut Matt Sause, CEO von Roche Diagnostics, kann der Algorithmus die Aufenthaltsdauer in der Notaufnahme durch einen frühen Ausschlussweg um mehr als drei Stunden verkürzen.
Der Algorithmus gibt Empfehlungen für Rule-In, Rule-Out oder Beobachtung und wählt automatisch den passenden ESC-Pfad basierend auf dem Zeitpunkt der Blutentnahme aus. Derzeit in Europa, dem Nahen Osten und Asien verfügbar, mit geplanter zukünftiger Verfügbarkeit in den USA, integriert sich das System in bestehende Notaufnahme-Workflows über elektronische Gesundheitsakten und Laborinformationssysteme.
- CE Mark approval received for new diagnostic algorithm
- Potential to reduce emergency department visit times by over 3 hours
- Integration capability with existing hospital systems reduces implementation barriers
- Expansion of diagnostic product portfolio in large cardiovascular market
- Not yet available in the key US market
- Requires integration with existing hospital infrastructure which may limit adoption
- Roche, in collaboration with Universitätsklinikum Heidelberg, has developed a Chest Pain Triage algorithm – a CE-marked IVD medical device1 set to transform cardiac care
- This novel algorithm offers a standardised assessment, helping emergency room doctors to make confident clinical decisions in ruling in or ruling out heart attacks (acute myocardial infarction)
- Cardiovascular disease causes a third of worldwide deaths2, with chest pain being the second highest reason for emergency department (ED) visits3
Basel, 23 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the introduction of its innovative Chest Pain Triage algorithm as part of the navifyⓇ Algorithm Suite. This groundbreaking algorithm is designed to more quickly and accurately detect Acute Coronary Syndrome (ACS) in patients presenting with chest pain, one of the most common reasons for Emergency Department (ED) visits. As EDs are typically one of the most crowded hospital units, leading to challenges to swiftly diagnose critical conditions, such as chest pain.4 This new algorithm was developed in collaboration with Universitätsklinikum Heidelberg.
The Chest Pain Triage algorithm leverages state-of-the-art diagnostic technologies, including high-sensitivity cardiac troponin testing, to provide healthcare professionals with timely and reliable data to differentiate between cardiac and non-cardiac chest pain. This advanced algorithm is part of a wider integrated offering from Roche to address ACS, including the use of the cardiac troponin T Assay and integration with existing lab solutions, offering an efficient and comprehensive approach to patient triage in emergency settings. The Chest Pain Triage algorithm also leverages the European Society of Cardiology’s (ESC) guidelines, and leading cardiologists and emergency medicine experts contributed to the development of the algorithm.
"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.5”
The new algorithm aims to identify patients genuinely at risk by accurately identifying non-cardiac chest pain cases through a definitive Rule-In, Rule-Out or Observe recommendation according to the ESC guidelines. The algorithm simplifies decision making by automatically selecting the proper ESC 0/1, 0/2, or 0/3 accelerated pathway, based on the timing of the blood sample collection. This has the potential to reduce unnecessary hospital admissions and associated costs. The algorithm also expedites the treatment process for patients with true ACS with Rapid Assessments of chest pain onset more than three hours before the first blood sample. In addition, it includes a medical dossier for clinician support, and simplifies documentation by allowing doctors to easily copy recommendations and results into patient records. For more information, please visit the Chest Pain Triage algorithm site.
The development of the Chest Pain Triage algorithm is part of Roche's commitment to early identification and treatment of Cardiovascular disease. The algorithm is available in Europe, the Middle East, and Asia, with availability in the United States at a later date, through Roche’s navify Algorithm Suite, and can be integrated into current emergency department workflows*. Roche's cardiometabolic portfolio supports faster and more accurate triage decisions, and future ACS offerings will combine next-generation digital algorithms, biomarkers, near patient care devices, and laboratory analyzers.
The navify Algorithm Suite is a cloud-based platform hosting clinical algorithms from Roche and partners. It provides labs and hospitals with direct workflow integration through Electronic Health Records (EHR) and Lab Information Systems (LIS) for faster and more efficient processes.
About navify
The navify portfolio from Roche includes more than 30 digital solutions for labs, hospitals and patients worldwide. navify solutions connect the healthcare community with a robust digital infrastructure to integrate data efficiently and to accelerate clinician access to innovations as well as operational and medical insights. This work includes collaborating with other innovative companies such as Fortinet in cybersecurity services. The navify platform is designed to deliver security at every step of the data analytical process. All data is encrypted at rest and in transit. The solution is operated in compliance with applicable laws and regulations in the USA with HIPAA (Health Insurance Portability and Accountability) as well as with GDPR (General Data Protection Regulation) regulations in Europe.
Healthcare professionals can visit navify Marketplace to browse and request a growing number of next generation digital solutions from Roche and other companies — all designed to drive operational and clinical excellence, built on the foundational pillars of digital trust. More information is also available at navify.com.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
* Availability will depend on the specific market and country in some cases. Please consult a local Roche representative for the availability of the chest pain algorithm in your market
References
[1] European Union: EUR-Lex. Chest Pain Triage algorithm registration [Internet: accesses March 24, 2025] Chest Pain Triage algorithm is an in-vitro diagnostic (IVD) medical device CE-marked (NB 0123) under the requirements laid out in the IVD regulation (EU) 2017/746 (IVDR).
[2] Saloni D et al. Cardiovascular Diseases. [Internet: accessed March 24, 2025]. Available from: https://ourworldindata.org/cardiovascular-diseases?insight=cardiovascular-diseases-are-the-most-common-cause-of-death-worldwide#all-charts
[3] Yukselen Z, Majmundar V, Dasari M, Arun Kumar P, Singh Y. Chest Pain Risk Stratification in the Emergency Department: Current Perspectives. Open Access Emerg Med. 2024 Feb 4;16:29-43. doi: 10.2147/OAEM.S419657. PMID: 38343728; PMCID: PMC10853047
[4] Sartini M, et al. Overcrowding in Emergency Department: Causes, consequences, and solutions – a narrative review. Healthcare (Basel). 2022 Aug;10(9):1625)
[5] Anand A, et al. High-sensitivity cardiac troponin on presentation to rule out myocardial infarction: A stepped-wedge cluster randomized controlled trial. Circulation. 2021 Jun;143(23):2214-2224)
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