Coronary artery disease

Streamlining clinical decision-making in acute coronary syndrome.

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Illustration of a blood sample tube medical report heart and ECG line representing coronary artery disease diagnosis

Streamlining clinical decision-making in acute coronary syndrome

Our commitment

We discover and develop novel, high-quality, accurate solutions for acute coronary syndrome (ACS)

As the leader in in vitro diagnostics, we discover and develop novel, high-quality, accurate solutions for ACS diagnostics, through:

  • Continuous innovation: With a rich legacy of innovation, we are committed to addressing both current and future unmet needs in ACS by delivering highly sensitive cardiac biomarker testing, integrated digital solutions, and cutting-edge technologies to the market. 
  • Connecting solutions: By integrating next-gen assays, pioneering biomarkers, and advanced digital algorithms, we aim to deliver a holistic and personalized solution for seamless interconnectivity and standardization across testing platforms and settings.1
  • Creating evidence: We have been dedicated to troponin assay research for 30 years and are continuing to produce valuable evidence and raise standards in global clinical diagnostic studies.2
Disease burden

Coronary artery disease poses a major healthcare burden

Coronary artery disease, also known as coronary heart disease, is the most common cardiovascular condition globally, with an estimated prevalence of 250 million. Around nine million people die from it each year, accounting for one in seven deaths globally, making coronary artery disease one of the world’s biggest killers.3 Of these deaths approximately seven million people die from the acute subtype of coronary artery disease which is acute coronary syndrome.4

With so many cases around the world, coronary artery disease has a significant economic impact on health systems due to associated costs such as hospitalizations, surgical procedures, clinical and emergency visits, and medications. In most countries, the costs of coronary artery disease radically exceed the per capita health expenditure, largely driven by acute episodes. It is estimated that 129 million disability adjusted life years are lost annually to acute coronary syndrome alone.4,5 Prompt diagnosis and treatment are essential to minimize complications and improve outcomes.6

Diagnostic challenges and impact

A diagnostic and logistical challenge for healthcare systems

Chest pain is a leading cause for hospital attendance, with seven million presentations annually in the US alone.7 Given the heart’s proximity to other organs, chest pain can be attributed to a variety of conditions, but for patients with AMI, it is critical that they receive early, accurate, and confident diagnosis and treatment. Unfortunately, several challenges to this exist:

  • Overcrowding in hospital emergency departments (EDs) is a critical challenge, blocking timely and effective care in the most high-risk patients, including those with AMI. This is compounded by staff shortages in EDs, which compromise triage quality, particularly when demand is high, resulting in impaired patient assessments and increased errors8

  • Decentralized care and rapidly changing diagnostic technologies leave labs with the challenges of combining data streams from different sources and managing complex workflows9

  • Labs are also under pressure to meet growing testing demands with faster turnaround times, all while operating with limited budgets and resources

Embracing new technologies and implementing new protocols is key to tackling current and future challenges.10 Roche provides a range of new biomarkers, new platforms, and digital solutions that enable seamless integration of data streams across labs and POC offerings. enabling continuity of cardiovascular care across multiple disciplines and organizations.11

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Benefits of Roche diagnostic and management solutions for acute coronary syndrome

Continuing innovation

We are committed to raising the standard in ACS diagnostics

Our aim is to make diagnosis faster and more accurate with lab-equivalent performance across the patient pathway in every care setting.

As the cornerstone of ACS diagnostics, high-sensitivity troponin T (TnT hs) assays, as part of guideline-recommended algorithms, have been associated to reduce length of stay in the ED, improve ED direct discharge rates, and preserve the use of downstream diagnostic resources.12-14 At Roche, we were the first to develop a TnT hs for rapid rule out, and are building on this success with Elecsys Troponin T hs Gen 6:15,16

  • As part of the ESC 0h/1h algorithm, TnT hs enables rapid rule out of AMI, helping to safely and efficiently unload EDs without increasing use of limited diagnostic resources.12-14
  • Elecsys® Troponin T hs Gen 6 delivers higher sensitivity at even lower troponin levels and market-leading resistance to hemoglobin interference.* This aims to deliver greater confidence in fast decision-making for more patients.16

We are dedicated to providing Point of Care (POC) solutions to improve early identification of AMI in decentralized settings. Our ambition is for every patient with suspected ACS to receive the right care, at the right time, in the right setting, with greater confidence.

Connecting solutions

Holistic solutions for seamless interconnectivity and standardization across all settings.

By combining the latest high-sensitivity assays with integrated digital support tools, we aim to empower more accurate clinical decisions across all ACS healthcare settings. Our optimized digital solutions aim to seamlessly integrate data streams across lab and POC offerings.11

  • Integrated algorithms: Our solution directly integrates the most recent evidence-based algorithms into your existing workflows. Our CE-marked Chest Pain Triage algorithm is designed to help efficiently and compliantly triage suspected ACS patients.17,18
  • Secure connections: Cybersecurity and data privacy are embedded and continuously updated in our digital tools. We aim to provide peace of mind when securely accessing tools needed to stay compliant, drive value-based healthcare, and improve patient care.17-18, 21-22
  • Actionable insights: navify® Analytics for the lab provides actionable insights to help improve operational efficiency. This enabled interventions that reduced operational time in the pre-analytical phase by 68% and reduced test execution time within the workflow by 45% for the diagnosis of AMI.21
  • Optimized workflows: The Roche Healthcare Consulting team is expert in optimizing workflows and leveraging customer knowledge, best practices, established standards, and return on investment activities to find personalized solutions.22
Creating evidence

Leading the way in cutting-edge research

We have been dedicated to troponin assay research for 30 years and are continuing to produce valuable evidence and raise standards in global clinical diagnostic studies:2

  • We are unique in the number of groundbreaking studies we support, including key guideline-shaping studies (TRAPID-AMI, BABA project, RAPID-TnT, and RAPID-CPU), which have been instrumental in driving the adoption of the rapid, safe, and efficient ESC 0h/1h algorithm*12-14, 23-25
  • Our high-sensitivity troponin T assay has been studied in over 2400 publications, supporting the healthcare community to make informed decisions in their care26
  • We have actively supported independent investigator-initiated studies that have driven practice-enhancing updates to periprocedural myocardial injury guidelines27,28
  • The Roche-led TSIX study program of the Elecsys® Troponin T hs Gen 6 assay sets a new benchmark in troponin research29
    • Comprehensive study performed across 80 sites globally
    • Large, global, and diverse healthy population enrolled, following the latest IFCC criteria
    • Provides global and sex-specific Elecsys® Troponin T hs Gen 6  URLs, supporting standardized decision-making
  • We are committed to innovating and developing new biomarkers that aim to enhance the early diagnosis and management of patients with suspected AMI and improve the quality of frontline care

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*The ESC 0/1-hour algorithm was originally validated using earlier high-sensitivity cardiac troponin assays. Assay-specific cut-offs must be applied according to local validation and regulatory approval.

 

References

  1. Stepinska J, et al. Diagnosis and risk stratification of chest pain patients in the emergency department: focus on acute coronary syndromes. A position paper of the Acute Cardiovascular Care Association. Eur Heart J Acute Cardiovasc Care. 2020;9(1):76-89.
  2. Danese E and Montagnana M. An historical approach to the diagnostic biomarkers of acute coronary syndrome. Ann Transl Med. 2016;4(10):194.
  3. British Heart Foundation. Global Cardiovascular Disease Factsheet [Internet; cited 2025 Nov 10]. Available from: https://www.bhf.org.uk/-/media/files/for-professionals/research/heart-statistics/bhf-cvd-statistics-global-factsheet.pdf
  4. Vedanthan R, et al. Circ Res. 2014;114:1959–1975
  5. Lozano R, et al. Lancet. 2012;380:2095–2128.
  6. Rittiphairoj T, et al. The economic burden of ischaemic heart diseases on health systems: a systematic review. BMJ Global Health. 2025;10:e015043.
  7. Dawson LP, et al. Coronary Atherosclerotic Plaque Regression: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022;79:2333-48.
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  10. Ski CF, et al. Integrated care in cardiovascular disease: a statement of the Association of Cardiovascular Nursing and Allied Professions of the European Society of Cardiology. Eur J Cardiovasc Nurs. 2023;22(5):e39-e46.
  11. F. Hoffmann-La Roche Ltd. navify® point of care digital solutions [Internet; cited 2025 Nov 10]. Available from: https://diagnostics.roche.com/global/en/products/product-category/lab-type/point-of-care-testing-poct/digital-solutions.html
  12. Chew DP, et al. A Randomized Trial of a 1-Hour Troponin T Protocol in Suspected Acute Coronary Syndromes: The Rapid Assessment of Possible Acute Coronary Syndrome in the Emergency Department With High-Sensitivity Troponin T Study (RAPID-TnT). Circulation. 2019;140(19):1543 – 56.
  13. Stoyanov K, et al. RAPID-CPU: a prospective study on implementation of the ESC 0/1-hour algorithm and safety of discharge after rule-out of myocardial infarction. Eur Heart J Acute Cardio Care. 2020;9(1):39–51
  14. Twerenbold R, et al. Outcome of Applying the ESC 0/1-hour Algorithm in Patients With Suspected Myocardial Infarction. JACC. 2019;74:483–94
  15. Collinson P. Update on global conversion to high sensitivity cardiac troponin assays. J Lab Precis Med. 2023;8:15.
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  17. F. Hoffmann-La Roche Ltd. navify®: Chest Pain Triage Algorithm. [Infosheet; cited 2025 Nov 10]. Available from: https://assets.navify.roche.com/f/305562/x/c8d1b0dc6e/mc-12243-infosheet-algorithm-suite-chest-pain-triage-2-pager-8-aug-2023.pdf
  18. F. Hoffmann-La Roche Ltd. navify®: Algorithms for cardiology. [Infosheet; cited 2025 Nov 10]. Available from: https://assets.navify.roche.com/f/305562/x/04cfdc95a8/mc-12752-navify-algorithms-for-cardiology-patient-management-sheet.pdf
  19. F. Hoffmann-La Roche Ltd. Chest Pain Triage Algorithm Method Sheet. (v6.0). 2024.
  20. F. Hoffmann-La Roche Ltd. Data on file.
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  24. Reichlin T, et al. Prospective validation of a 1-hour algorithm to rule-out and rule-in acute myocardial infarction using a high-sensitivity cardiac troponin T assay. CMAJ. 2015;187(8):E243-52.
  25. Mueller C, et al. Multicenter Evaluation of a 0-Hour/1-Hour Algorithm in the Diagnosis of Myocardial Infarction With High-Sensitivity Cardiac Troponin T. Ann Emerg Med. 2016;68(1):76-87.
  26. F. Hoffmann-La Roche Ltd. Data on file.
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  28. Thompson A, et al. 2024 AHA/ACC/ACS/ASNC/HRS/SCA/SCCT/SCMR/SVM Guideline for Perioperative Cardiovascular Management for Noncardiac Surgery: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024;150(19):e351-e442
  29. Daniels LB, et al. Unpublished manuscript in preparation.