Precision, Speed, and Standardization: How Roche’s Gen 6 Troponin Test Is Changing Emergency Cardiac Care

Chest pain is one of the most common reasons for visits to emergency departments worldwide, yet fewer than one in ten cases actually result in a heart attack. Rapid and reliable testing is crucial not only for saving lives but also for alleviating the pressure on overstretched emergency care systems. Roche Diagnostics, a global leader in in-vitro diagnostics, has made significant progress with the launch of its sixth-generation Elecsys® Troponin T high-sensitivity (hs) test, which has recently received CE Mark approval.

Validated in one of the largest and most diverse clinical trial programs for a cardiac biomarker, the Elecsys Troponin T hs Gen 6 test offers enhanced analytical sensitivity, superior robustness, and unprecedented standardization demonstrating traceability to NIST reference materials. This test enables quicker and more confident determination of whether a patient is experiencing an acute myocardial infarction (AMI), allowing clinicians to make life-saving decisions within minutes.

In an interview with Medtech Spectrum, Olivier Gillieron, Life Cycle Leader for Cardiometabolic and Neurology at Roche Diagnostics, discusses how the Gen 6 test is transforming cardiac diagnostics, its impact on improving efficiency in emergency departments, and Roche's broader vision for advancing cardiovascular care through innovation, digital integration, and clinical precision.

How does the sixth-generation Elecsys Troponin T hs test improve upon earlier versions in terms of sensitivity, specificity, and clinical utility for diagnosing acute myocardial infarction (AMI)?

Roche’s new Elecsys® Troponin T hs Gen 6 test, which was recently granted CE Mark approval, offers improved sensitivity, robustness and accuracy for detecting acute myocardial infarction (AMI), commonly known as heart attack. The test’s accuracy and reliability were validated in more than 13,000 participants across diverse populations in the US, EU, China, and Japan,

making it one of the most comprehensive clinical trial programs ever conducted for a cardiac Troponin biomarker.

The new generation Troponin T hs assay offers significant advantages, addressing critical unmet needs. A key improvement is its tenfold enhanced resistance to hemoglobin interference.

Hemolysis, a common issue leading to sample rejection, often causes delays and anxiety for patients presenting to emergency departments with suspected heart attacks. Eliminating this interference is a huge value driver for ED physicians and laboratory professionals, avoiding

potential delays in a care setting where every minute counts.

The Gen 6 test offers enhanced analytical sensitivity in the low measuring range and has a lower coefficient of variation (CV). Therefore, the test exceeds the latest International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) criteria for high-sensitivity assays. This means it can accurately detect very small changes in troponin levels, which is crucial for patients presenting with early acute coronary syndrome (ACS) and for cardiovascular risk assessment in the asymptomatic population.

The test’s analytical sensitivity was proven by its ability to detect measurable troponin levels in almost 90 per cent of the healthy reference population compared to a requirement of 50 per cent for hs-troponin assays.1

The assay was developed using a new reference material traceable to internationally recognised standards (NIST), which eliminates variability in results. This ensures high accuracy, clarity, and consistency in its measurements and comparability across settings. No currently available troponin assay uses NIST-traceable reference material, making this unique among troponin tests for heart attack. This level of standardisation supports consistent clinical decisions, aligns with

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 Augusinternational guidelines, and allows for easier integration into global research and medical practices.

Chest pain is a leading reason for emergency visits, yet only a small fraction of cases are actual heart attacks. How does this test help clinicians more confidently and quickly rule in or rule out AMI to reduce overcrowding and delays in emergency departments?

Although chest pain is one of the top three reasons people visit emergency departments,2 less than 10 per cent of cases turn out to be heart attacks.3 A test that can quickly and reliably rule in or rule out heart attacks is vital because it helps reduce anxiety for patients, lightens the burden on overstretched emergency services, and ensures resources are targeted to those who need them most.

Cardiac troponin is a heart muscle protein which is released into the blood when the heart muscle is damaged during a heart attack, making it a critical marker for heart health. Even the smallest changes in troponin levels provide a crucial indication of injury, making it an essential tool for quickly identifying heart attacks and guiding life-saving treatment decisions.

The PERFORM-TSIX study, recently presented at the European Society for Emergency Medicine (EUSEM) in Vienna demonstrated the real-world impact of the Elecsys® Troponin T hs Gen 6 test. The study showed that the test enabled 56.6 per cent of patients to be safely discharged early with 99.7% confidence they were not having a heart attack.4,5

Furthermore, data presented at EUSEM also demonstrated improvements in single-sample rule out strategies, showing that this test was able to rule out significantly more patients with a single sample. This could lead to further reductions in length-of-stay in the ED.

The test’s improved precision and robustness can save vital time, enabling clinicians to confidently interpret the results without needing readings verified by a lab, quickly identifying patients with a heart attack so they can receive the life-saving care they need when every second counts. As the test also reliably rules out heart attack in patients presenting with chest pain for other reasons, it can reduce unnecessary admissions and tests, ensuring healthcare

2 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

3 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.

4 A Study of Elecsys® Troponin T hs Gen 6 in Participants With Symptoms of Acute Coronary Syndrome (PERFORM-TSIX), ClinicalTrials.gov ID NCT06734117, available at URL: https://clinicaltrials.gov/study/NCT06734117?term=NCT06734117&rank=1. Last accessed September 2025.

5 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. resources are focused on those who most need urgent care, reducing pressure on emergency services.

With many European emergency departments reporting frequent overcrowding, what role do you see this test playing in optimizing patient flow and resource allocation across healthcare systems?

Overcrowding in European emergency departments is a major issue with 49 per cent of emergency departments in Europe reporting overcrowding on a frequent basis, impacting on the resources available and quality of care.6 Although there are numerous causes for overcrowding, patients often require specialist consultations or additional diagnostic investigations.7

The Troponin T hs Gen 6 test can play a crucial role in getting patients the right care by pinpointing those experiencing AMI from those whose symptoms, such as chest pain, are being caused by other conditions.

By delivering fast, precise, reliable results, and eliminating interferences, the test ensures that patients who are experiencing AMI can receive timely, life-saving treatment, while those who are not avoid unnecessary procedures and can be given the right care for their condition.

Furthermore, the single-sample rule-out strategy, presented at EUSEM, holds the potential to further optimize patient flow. This helps reduce patient anxiety and unnecessary admissions, avoids the need for additional tests, and relieves pressure on overstretched emergency care services to focus resources where they are needed most.

The Elecsys Troponin T hs Gen 6 test recently received CE Mark approval. What does this milestone mean for Roche and its rollout strategy in Europe and globally?

With a 30-year legacy in troponin innovation, Roche was the first company in the world to introduce high-sensitivity troponin tests, and our troponin test was the first to receive FDA

approval. This sixth-generation test reinforces our role as a cardiac diagnostics leader, offering clinicians and labs a solution built on a solid foundation of trust and scientific excellence.

This test is the first in a series of anticipated approvals in the area of coronary artery disease (CAD), and reflects the company's investment in the future of CAD management. As well as a

portfolio of innovative tests which enable consistent and precise biomarker measurements to be reliably compared across healthcare settings, this includes future acute coronary syndrome (ACS) offerings that will combine next-generation digital algorithms, biomarkers, point-of-care devices, and laboratory analyzers.

6 https://pmc.ncbi.nlm.nih.gov/articles/PMC9498666/

7 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.

The TSIX Study Program showed promising results for precision in both diagnosis and exclusion of AMI. Could you share more details on how these findings might influence adoption by clinicians and guideline committees?

TSIX is a global clinical trial program designed to evaluate and validate the performance of Roche’s Troponin T hs Gen 6 test for diagnosing heart attack. As one of the most comprehensive clinical trial programs ever conducted for a cardiovascular biomarker, it reflects our commitment to advancing cardiovascular diagnostics with rigorous evidence, supporting clinicians with reliable data to make critical decisions, and ultimately improving patient outcomes globally.

The program consists of two key studies: REF-TSIX and PERFORM-TSIX.

The REF-TSIX study defined the standard upper reference limits (URLs) for troponin levels in healthy individuals, including sex-specific values. The findings established new URLs for cardiac troponin T, with a uniform 99th percentile URL of 27 ng/L for the general population and

sex-specific URLs of 18 ng/L for females and 32 ng/L for males.

PERFORM-TSIX was a prospective, longitudinal study evaluating the test’s clinical performance in diagnosing acute AMI in 5,600 patients presenting with signs or symptoms of acute coronary syndrome (ACS). It collected and analyzed samples across multiple time points (such as on arrival and at three and six hours post-presentation). The study validated the performance of the ESC 0 h/1 h and 0 h/2 h algorithms, enabling clinicians to triage ~70 per cent of the population presenting to the ED with suspected ACS/heart attack.

Additionally, the test far exceeds the latest high-sensitivity IFCC criteria, demonstrating exceptional accuracy and precision. It also offers a tenfold improvement in resistance to hemolysis, eliminating the need for re-sampling caused by hemoglobin interference, which can delay results by up to 90 minutes and cause significant anxiety for patients waiting for clarity on whether or not they are having a heart attack. By providing highly reliable and accurate results the first time, the test reduces these delays, supports faster decision-making, and improves the patient experience.

Looking ahead, how does Roche envision the role of high-sensitivity cardiac biomarkers evolving in emergency medicine, and what innovations are you prioritizing to further support cardiology and acute care diagnostics?

The Elecsys® Troponin T hs Gen 6 test exemplifies Roche’s commitment to improving diagnostic accuracy, delivering high sensitivity at low troponin values, and addressing critical gaps in the diagnosis and management of heart attacks.

We also believe that high-sensitivity troponins may have prognostic value in other populations beyond those experiencing a heart attack. For example, they may help identify currently asymptomatic individuals who carry risk factors, providing early indicators of cardiovascular risk. Further studies will be key to exploring how this new high-sensitivity Troponin T test can predict risk in diverse populations and support preventative care. 

Looking ahead, the test's seamless integration into our comprehensive ecosystem of biomarkers, cutting-edge digital tools, and standardized diagnostic platforms is a pivotal component of the company's ACS Ecosystem offering. This strategic initiative, building on the TSIX Study Program, aims to revolutionize the standard of care for managing suspected heart attacks.

Our aim is to equip clinicians with the most complete and connected toolkit for chest pain triage, integrating innovative biomarkers, high-value digital tools, and advanced algorithms. By unifying diagnostic options and diagnostic pathways, and offering flexible tools, we envision a future where healthcare systems can deliver the right care, in the right setting, at the right time, reducing overcrowding in emergency departments, and improving patient outcomes globally.