Study of more than 13,000 individuals demonstrates improved precision for emergency department triage and patient outcomes.
Roche announced primary results from its TSIX Study Program showing that the company’s sixth-generation high-sensitivity Troponin T test can identify acute myocardial infarction and rule out heart attacks with high precision in emergency department settings.
The Elecsys Troponin T hs Gen 6 test results were presented at the European Society for Emergency Medicine 2025 and the European Society of Cardiology 2025. The study program recruited more than 13,000 individuals across the US, China, Japan, and the EU, representing what Roche calls the largest global clinical study program of its kind for troponin testing.
“Our new test enables clinicians to detect even the smallest elevations in troponin levels—a critical biomarker for heart attack—with high confidence,” says Matt Sause, CEO of Roche Diagnostics, in a release. “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.”
The US Food and Drug Administration-cleared test was also recently granted CE Mark.
Study Results Show High Clinical Performance
Forming the basis for regulatory approval, the TSIX study program recruited a total of over 13,000 individuals. The REF-TSIX study was designed to establish the standard upper reference limits (URLs) for troponin levels in the blood. 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. 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.
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, presenting to emergency departments with symptoms of acute coronary syndrome. 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.
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. Moreover, the study data showed that 56.6% of patients were able to be discharged in the first hours after presentation with a negative predictive value of 99.7%, underlining its excellent clinical performance.
Photo caption: Troponin T test
Photo credit: Roche
