Roche introduces sixth-generation troponin T test with enhanced diagnostic precision
Roche has unveiled results from its comprehensive TSIX Study Program evaluating a new high-sensitivity cardiac troponin T assay designed to improve acute myocardial infarction diagnosis in emergency settings. The sixth-generation test, recently granted CE Mark approval, demonstrates significant advances in sensitivity and accuracy for detecting cardiac events.
Global validation across diverse populations
The TSIX program represents the first global clinical study of its kind in troponin testing, enrolling over 13,000 participants across the United States, China, Japan and the European Union. Results were presented at the European Society of Cardiology Congress 2025 and the European Society for Emergency Medicine 2025.
The REF-TSIX component established upper reference limits of 27 ng/L for the overall population, with sex-specific thresholds of 18 ng/L for females and 32 ng/L for males. These findings align with International Federation of Clinical Chemistry and Laboratory Medicine benchmarks for clinical diagnostics.
Clinical performance in emergency departments
The PERFORM-TSIX study enrolled 5,631 patients across 50 sites presenting with acute coronary syndrome symptoms. The prospective, multicentre cohort study collected up to five samples at intervals following emergency department presentation.
“Our new test enables clinicians to detect even the smallest elevations in troponin levels – a critical biomarker for heart attack – with high confidence,” said Matt Sause, CEO of Roche Diagnostics. “This ensures that in a situation when every second counts, patients receive the life-saving care they need at the earliest opportunity.” The assay met its primary endpoint using the universal 99th percentile upper reference limit at three hours post-presentation. Notably, 56.6% of patients could be discharged within the first hours with a negative predictive value of 99.7%, demonstrating strong rule-out capability.
Addressing emergency department pressures
With chest pain ranking among the top three reasons for emergency visits, yet only one in ten patients actually experiencing myocardial infarction, accurate triage remains critical. The test supports efficient resource allocation in settings where 49% of European emergency departments report frequent overcrowding.
The Elecsys Troponin T hs Gen 6 assay builds on Roche’s 30-year legacy in troponin innovation, during which the company introduced the first high-sensitivity troponin tests globally and received the first FDA approval for troponin testing.
For more information, visit: www.roche.com
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