Roche secures CE Mark for automated latent tuberculosis blood test
pharmafile | July 14, 2026 | News story | Research and Development | Roche, tuberculosis infection
Roche has received CE Mark approval for its Elecsys IGRA TB test, an automated blood test designed to improve the detection of tuberculosis infection (TBI), also known as latent tuberculosis.
The test provides results in under 24 hours, with the interferon gamma release assay (IGRA) itself taking around 19 minutes per patient, approximately half the processing time of conventional IGRA methods.
Tuberculosis remains one of the world’s leading infectious diseases, with an estimated 10.7 million people developing the disease and 1.23 million dying from it in 2024. Although latent tuberculosis causes no symptoms, around 5-10% of infected individuals will go on to develop active disease during their lifetime.
It is estimated further that around 25% of the total world population may have been infected with the bacteria that cause tuberculosis.
Matt Sause, CEO of Roche Diagnostics, said: “Addressing latent tuberculosis is critical to reducing the global health burden of this devastating disease, and that begins with better, more accessible testing.”
Unlike the traditional tuberculin skin tests, blood-based IGRA testing requires only one patient visit and is less affected by previous Bacillus Calmette-Guérin (BCG) vaccination, while reducing the need for specialist staff.
The Elecsys IGRA TB test also incorporates digital tools that automate result calculation, interpretation and reporting, helping laboratories improve efficiency while reducing manual workloads.
Clinical evaluation demonstrated 91.1% positive percent agreement and 94.6% negative percent agreement compared with standard-of-care methods, with 100% relative sensitivity in patients with bacteriologically confirmed tuberculosis.
Roche said the assay complements its existing molecular tuberculosis testing portfolio, providing laboratories with an integrated approach to diagnosing both latent infection and active disease.
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