Data show Roche’s sixth-generation Troponin T test offers a new level of accuracy critical for diagnosing heart attacks
Roche (OTCQX: RHHBY) has announced significant results from its TSIX Study Program evaluating their new sixth-generation high-sensitivity Troponin T test for heart attack diagnosis. The study, involving over 13,000 participants, demonstrated the test's superior precision in identifying acute myocardial infarction (AMI) and ruling out non-cardiac cases.
The Elecsys® Troponin T hs Gen 6 test, which recently received CE Mark approval, addresses a critical healthcare need, as chest pain accounts for a significant portion of emergency visits, though only 10% of cases are actual heart attacks. With 49% of European emergency departments experiencing frequent overcrowding, this improved diagnostic tool enables more efficient patient triage and resource allocation.
Roche (OTCQX: RHHBY) ha annunciato risultati significativi dal TSIX Study Program valutando il nuovo test di sesta generazione ad alta sensibilità per la Troponina T per la diagnosi di infarto. Lo studio, che ha coinvolto oltre 13.000 partecipanti, ha dimostrato la superiorità del test nell'identificazione dell'infarto miocardico acuto (AMI) e nello screening dei casi non cardiaci.
Il test Elecsys® Troponin T hs Gen 6, recentemente autorizzato con CE Mark, risponde a un bisogno critico nel settore sanitario, poiché il dolore toracico rappresenta una parte significativa delle visite d'emergenza, sebbene solo il 10% dei casi sia effettivamente un infarto. Con il 49% dei pronto soccorso europei che vivono frequenti affollamenti, questo strumento diagnostico migliorato permette un triage più efficace dei pazienti e una migliore allocazione delle risorse.
Roche (OTCQX: RHHBY) ha anunciado resultados significativos del TSIX Study Program evaluando su nueva prueba de troponina T hs de sexta generación de alta sensibilidad para el diagnóstico de ataque al corazón. El estudio, que incluyó a más de 13.000 participantes, demostró la mayor precisión de la prueba para identificar un infarto de miocardio agudo (AMI) y descartar casos no cardíacos.
La prueba Elecsys® Troponin T hs Gen 6, que recientemente obtuvo la aprobación CE, aborda una necesidad crítica en la atención sanitaria, ya que el dolor en el pecho representa una parte significativa de las visitas a emergencias, aunque solo el 10% de los casos sean infartos. Con el 49% de los servicios de emergencia europeos experimentando sobrecarga frecuente, esta herramienta diagnóstica mejorada permite un triaje más eficiente de los pacientes y una asignación de recursos más eficaz.
로슈(RHHBY)는 심근경색 진단을 위한 새로운 6세대 고감도 트로포닌 T 검사를 평가하는 TSIX 연구 프로그램의 중요한 결과를 발표했습니다. 연구에는 13,000명 이상의 참가자가 포함되었으며, 급성 심근경색(AMI)을 식별하고 비심장성 케이스를 배제하는 데 있어 검사 정확도의 우수성을 입증했습니다.
최근 CE 마크를 받은 Elecsys® Troponin T hs Gen 6 검사는 가슴 통증이 응급실 방문의 상당 부분을 차지하지만 실제로 심근경색은 약 10%에 불과하다는 중요한 보건 수요를 다룹니다. 유럽 응급실의 약 49%가 자주 과밀한 상황에서 이 개선된 진단 도구는 환자 선별과 자원 배치를 보다 효율적으로 만들어 줍니다.
Roche (OTCQX: RHHBY) a annoncé des résultats significatifs du TSIX Study Program évaluant leur nouveau test Troponine T hs de sixième génération à haute sensibilité pour le diagnostic de l’infarctus du myocarde. L’étude, impliquant plus de 13 000 participants, a démontré la précision supérieure du test pour identifier l’infarctus du myocarde aigu et écarter les cas non cardiaques.
Le test Elecsys Troponin T hs Gen 6, qui a récemment obtenu le marquage CE, répond à un besoin critique en matière de soins de santé, car la douleur thoracique représente une part importante des visites d’urgence, bien que seulement 10% des cas soient des infarctus. Avec 49% des services d’urgence européens fréquemment saturés, cet outil diagnostique amélioré permet un triage des patients plus efficace et une meilleure allocation des ressources.
Roche (OTCQX: RHHBY) hat bedeutende Ergebnisse aus dem TSIX Study Program bekannt gegeben, das ihren neuen Troponin T hs Gen 6-Test mit hoher Empfindlichkeit zur Diagnose eines Herzinfarkts bewertet. Die Studie mit über 13.000 Teilnehmern zeigte die überlegene Präzision bei der Erkennung eines akuten Myokardinfarkts (AMI) und beim Ausschluss nicht-kardiologischer Fälle.
Der Elecsys Troponin T hs Gen 6-Test, der kürzlich die CE-Kennzeichnung erhalten hat, adressiert einen kritischen Bedarf im Gesundheitswesen, da Brustschmerzen einen großen Teil der Notaufnahmen ausmachen, jedoch nur 10% der Fälle ein Herzinfarkt sind. Da 49% der europäischen Notaufnahmen häufig überlastet sind, ermöglicht dieses verbesserte diagnostische Instrument eine effizientere Patienten-Triage und Ressourcenallokation.
روش (OTCQX: RHHBY) أعلنت عن نتائج مهمة من برنامج TSIX للدراسة يقيم اختبارهم الجديد إ signal Troponin T عالي الحساسية من الجيل السادس لتشخيص احتشاء عضلة القلب. شملت الدراسة أكثر من 13,000 مشارك، وأظهرت دقة أعلى في تحديد احتشاء عضلة القلب الحاد واستبعاد الحالات غير القلبية.
اختبار Elecsys Troponin T hs Gen 6، الذي حصل مؤخرًا على اعتماد علامة CE، يحدث حاجة صحية حاسمة، إذ أن ألم الصدر يمثل جزءًا كبيرًا من زيارات الطوارئ، رغم أن 10% فقط من الحالات هي احتشاء قلبي. مع وجود 49% من أقسام الطوارئ الأوروبية التي تعاني من الازدحام المتكرر، فإن أداة التشخيص المحسّنة هذه تتيح فرز المرضى بشكل أكثر كفاءة وتخصيص الموارد.
Roche (OTCQX: RHHBY) 已宣布在其 TSIX 研究计划中取得重要结果，评估他们的六代高灵敏度心肌肌钙蛋白T测试用于心脏病发作诊断。该研究涉及超过 13,000 名参与者，证明该测试在识别急性心肌梗死（AMI）和排除非心源性病例方面具有更高的准确性。
Elecsys Troponin T hs Gen 6 测试最近获得 CE 标志，满足关键医疗需求，因为胸痛是急诊就诊的主要原因之一，尽管其中只有约 10% 是心梗。欧洲急诊科普遍拥挤，约 49% 的急诊室经常过度拥挤，这一改进的诊断工具使患者分诊和资源分配更高效。
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- Recently granted CE Mark, the novel test delivers improved sensitivity and accuracy for faster and more reliable diagnosis in emergencies.
- The test helps clinicians quickly identify heart attack and rule out non-cardiac causes, ensuring patients receive the care they need at the earliest opportunity.
- The global TSIX clinical study involved more than 13,000 participants, validating performance across a diverse population that reflects real-world healthcare settings.1,2
Basel, 30 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced the primary results from the TSIX Study Program, which evaluated the performance of its new sixth-generation high-sensitivity Troponin T test for diagnosing heart attacks. Presented at the European Society for Emergency Medicine (EUSEM) 20252 and the European Society of Cardiology (ESC) 20251, the study results showed that the Elecsys® Troponin T hs Gen 6 test was able to identify acute myocardial infarction (AMI), or heart attack, and identify those not having an AMI, with a high level of precision.2,3 This supports the efficient triage of patients arriving at the emergency department, ensuring healthcare resources can be focused where they are needed most. This data announcement follows the recent CE Mark approval for the test.
As one of the top three reasons for emergency care visits,4 chest pain creates significant anxiety and uncertainty for patients whilst putting pressure on healthcare services. Yet only one in every ten patients who presents with symptoms will actually be experiencing a heart attack.5 With
"Coronary artery disease continues to place an immense strain on global health systems, particularly in emergency care, where cases of chest pain are among the most challenging presentations to evaluate,” said Matt Sause, CEO of Roche Diagnostics. “Our new test enables clinicians to detect even the smallest elevations in troponin levels – a critical biomarker for heart attack – with high confidence. This ensures that in a situation when every second counts, patients receive the life-saving care they need at the earliest opportunity, and emergency services can prioritise resources to deliver care effectively to those in urgent need."
About Roche Diagnostics’ commitment to heart health
With a 30-year legacy in troponin innovation, Roche was the first company in the world to introduce high-sensitivity troponin tests. And Roche's troponin test was the first to receive FDA approval. Building on this legacy, the novel test is the first in a series of anticipated approvals for Roche, reflecting the company's vision for the future of coronary artery disease (CAD) management. This includes a portfolio of innovative tests that enable consistent and precise biomarker measurements to be reliably compared across healthcare settings. It also includes future acute coronary syndrome (ACS) offerings that will combine next-generation digital algorithms, biomarkers, near-patient care devices, and laboratory analysers.
About the TSIX Study Program
Forming the basis for regulatory approval, the comprehensive TSIX study program recruited a total of over 13,000 individuals.1,4 It is the first global clinical study program of its kind to be performed in the use of troponin testing, involving patients in the US, China, Japan and the EU, and reflects Roche’s ambition to work towards more standardised care across the world.
The REF-TSIX study was designed to establish the standard upper reference limits (URLs) for troponin levels in the blood.1 These limits represent the highest expected concentration of troponin in a healthy population, providing the benchmarks used to diagnose myocardial infraction. The study prospectively collected plasma and serum samples from a diverse global population to ensure the assay's accuracy across different demographics and healthcare settings. Data presented at European Society of Cardiology congress 2025 showed a 99th percentile URLs of 27 ng/L for the overall population and sex-specific URLs of 18 ng/L for females and 32 ng/L for males.1 These findings confirm the test's consistency and accuracy, meeting the highest benchmarks for clinical diagnostics as recommended by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).7
To validate the clinical performance of the newly established URLs, the prospective, international, multicenter, longitudinal cohort study PERFORM-TSIX enrolled 5,631 patients across 50 sites,2,4 presenting to emergency departments with symptoms of ACS. Up to five samples were collected at intervals after presentation at the emergency department, to provide a detailed assessment of the test's performance across time points.4
The study data demonstrated that the assay was highly effective at detecting heart attacks, meeting its primary endpoint using the universal 99th percentile URL at three hours post emergency department presentation.3 Moreover, the study data showed that
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.
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References
[1] Daniels LB et al. Establishing reference values in healthy participants for a next generation cardiac troponin T high-sensitivity assay – the REF-TSIX global reference study. Presented at European Society of Cardiology Congress. 2025 August
[2] Peacock WF et al. Primary results of PERFORM-TSIX, a prospective, international, observational, longitudinal cohort study evaluating clinical performance of the next generation cardiac troponin T high-sensitivity Gen 6 assay in acute coronary syndrome myocardial infarction. Presented at European Society of Emergency Medicine September 2025
[3] F. Hoffmann-La Roche Ltd. Elecsys® Troponin T hs Gen 6 Method Sheet. (v.2.0). 2025
[4] Audrey J. Weiss, Ph.D., and H. Joanna Jiang, Ph.D., Agency for Healthcare Research and Quality, Most Frequent Reasons for Emergency Department Visits, 2018. Available at: https://hcup-us.ahrq.gov/reports/statbriefs/sb286-ED-Frequent-Conditions-2018.jsp
[5] Fanaroff AC, Rymer JA, Goldstein SA, Simel DL, Newby LK. Does This Patient With Chest Pain Have Acute Coronary Syndrome?: The Rational Clinical Examination Systematic Review. JAMA. 2015 Nov 10;314(18):1955-65. doi: 10.1001/jama.2015.12735. PMID: 26547467.
[6] Velt KB, Cnossen M, Rood PPM, Steyerberg EW, Polinder S, Lingsma HF; CENTER-TBI investigators. Emergency department overcrowding: a survey among European neurotrauma centres. Emerg Med J. 2018 Jul;35(7):447-448. doi: 10.1136/emermed-2017-206796. Epub 2018 Mar 21. PMID: 29563151.
[7] Aakre, K. M., Saenger, A. K., Body, R., Collinson, P., Hammarsten, O., Jaffe, A. S., ... & Apple, F. S. (2022). Analytical considerations in deriving 99th percentile upper reference limits for high-sensitivity cardiac troponin assays: educational recommendations from the IFCC committee on clinical application of cardiac bio-markers. Clinical chemistry, 68(8), 1022-1030.
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