Healthcare
Roche receives CE Mark for blood test to identify tuberculosis infection
The Elecsys IGRA TB test expands global access to tuberculosis infection testing, advancing progress toward the World Health Organization's elimination targets.Performed on Roche’s industry-leading and widely available cobas immunoassay systems, the test enables laboratories to meet growing tuberculosis infection testing needs by reducing reliance on manual workflows through automation and digital solutions.The new solution provides rapid, high-throughput, and cost-effective tuberculosis testing
About this update from Roche Holding Ltd
Basel, 9 July 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that its Elecsys IGRA TB test has received the CE Mark, introducing a new blood testing solution for identifying tuberculosis infection (TBI, also known as latent TB) in routine laboratory settings. The new solution enables fast, simple, and efficient diagnosis, and can provide results in under 24 hours. The Interferon Gamma Release Assay (IGRA) itself takes just 19 minutes per patient to process, which is approximately half the time of currently used methods. Laboratories now have an option for IGRA testing, with faster turnaround and scalable throughput on Roche's systems. "Addressing latent tuberculosis is critical to reducing the global health burden of this devastating disease, and that begins with better, more accessible testing," said Matt Sause, CEO of Roche Diagnostics. "The Elecsys IGRA TB test brings an automated solution for latent TB to Roche's industry-leading immunoassay platforms, which will enable screening programs and drive significant progress toward achieving global TB elimination targets." Tuberculosis remains one of the world's most significant public health challenges, with an estimated 10.7 million people falling ill and 1.23 million losing their lives to the disease in 2024 alone.1 It is estimated that approximately a quarter of the global population may have been infected with the bacteria that cause tuberculosis.2 While the infection can lie dormant without causing symptoms, 5 to 10% of cases will progress to symptomatic disease during a person's lifetime.3 Diagnosis of tuberculosis infection is essential to breaking the cycle of disease progression and transmission, preventing severe health complications, and guiding decisions about preventive treatment in high-risk populations. Expanding access to reliable diagnostics remains critical to achieving the World Health Organization's (WHO) global elimination targets, which aim to decrease tuberculosis deaths by 90% and new cases by 80% by 2030.4 Blood-based IGRA tests and tuberculin skin tests are established methods for identifying tuberculosis infections. In addition to offering higher accuracy and reliability, IGRAs provide a less invasive alternative to skin tests, requiring only a single patient visit and reducing dependency on specialised healthcare staff. Unlike tuberculin skin tests, IGRAs show minimal interference from Bacillus Calmette-Guérin (BCG) vaccinations, which remain widely used worldwide.5