Novel Test Offers New Accuracy Level in Heart Attack Diagnosis

Chest pain is one of the top reasons people visit emergency departments, yet only about one in ten patients presenting with these symptoms actually have a heart attack. Emergency departments (EDs) face frequent overcrowding, making rapid, reliable triage critical to focus care where it is most needed. Now, a novel test has been shown to offer a new level of accuracy critical for diagnosing heart attacks.

Roche Diagnostics’ (Basel, Switzerland) test, Elecsys Troponin T hs Gen 6, is the latest advance in the company’s three-decade legacy of troponin innovation. The TSIX study program, a comprehensive global clinical effort involving more than 13,000 participants across the US, China, Japan, and the EU, highlighted the assay’s development and established robust reference limits for diverse populations. As part of that program, the REF-TSIX study derived 99th percentile upper reference limits (URLs) for the assay, which was 27 ng/L overall with sex-specific URLs of 18 ng/L for females and 32 ng/L for males, thus meeting the IFCC recommendations for clinical diagnostics.

To validate clinical performance, the PERFORM-TSIX prospective multicenter cohort enrolled 5,631 patients presenting with symptoms of acute coronary syndrome and collected up to five samples after ED presentation to assess test performance over time. The assay met its primary endpoint using the universal 99th percentile URL at three hours post presentation and supported early, safe rule-out: 56.6% of patients were able to be discharged within the first hours after presentation with a negative predictive value of 99.7%. These primary results were presented at the European Society for Emergency Medicine (EUSEM) and the European Society of Cardiology (ESC).

By improving sensitivity and precision, the assay supports faster, more reliable decision-making in emergency care and can reduce unnecessary admissions and diagnostic delay, helping health systems prioritize scarce resources. According to Roche, the Gen 6 test is the first in a series of anticipated approvals that will be paired with digital algorithms, near-patient devices, and laboratory analyzers to enable more standardized, point-of-care coronary artery disease (CAD) management worldwide. The company envisions this portfolio facilitating consistent biomarker measurement across settings and advancing next-generation acute coronary syndrome (ACS) offerings.

“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, Chief Executive Officer, Roche Diagnostics. “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 prioritize resources to deliver care effectively to those in urgent need.”