F. Hoffmann-La Roche Ltd: 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, delivers reliable results in under 24 hours and cuts standard processing times in half to just 19 minutes per patient.

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

Traditional IGRA testing often involves labour-intensive workflows and manual procedures that significantly burden laboratory resources. These demanding processes not only increase the risk of errors, but also create barriers for laboratories attempting to implement more reliable blood-based testing methods or scale their operations to meet the rising demand for tuberculosis infection diagnostics.

By pairing Roche's new Elecsys IGRA TB test with existing molecular cobas MTB and cobas MTB-RIF/INH assays, laboratories gain an integrated solution for managing both tuberculosis infection and active disease. The Elecsys IGRA TB assay will also feature a novel digital tool to fully automate result calculation, interpretation and reporting. This ensures rapid, reliable, and fully traceable results while freeing up valuable laboratory resources. To further reduce manual laboratory workloads, the Elecsys IGRA TB assay is designed to integrate seamlessly with third-party automated liquid handlers for front-end processes prior to tube incubation. Additionally, Roche's long-term automation roadmap includes plans to introduce fully integrated, proprietary front-end automation. This will allow laboratories to optimize their workflows now while preparing for complete, end-to-end operational efficiency in the future.

Clinical data
The performance of Elecsys IGRA TB was evaluated in a global, multi-centre study conducted at both low-incidence and high-incidence settings in the European, Western Pacific, African regions and regions of the Americas. In the intended use population, i.e. individuals currently requiring tuberculosis infection testing as part of their clinical care, Elecsys IGRA TB achieved 91.12% positive percent agreement (PPA) and 94.57% negative percent agreement (NPA) when compared to standard of care methods. In bacteriologically confirmed TB disease patients, Elecsys IGRA TB demonstrated a relative sensitivity of 100% compared to an established IGRA method. Furthermore, in accordance with established clinical trial protocols, the specificity of Elecys IGRA TB was estimated in a low-risk cohort and demonstrated a specificity of 95.32 %⁶. These results together demonstrate a highly reliable performance.

About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] WHO Global Tuberculosis Report 2025, available at URL: https://www.who.int/teams/global-programme-on-tuberculosis-and-lung-health/tb-reports/global-tuberculosis-report-2025
[2] Houben RM, Dodd PJ. The Global Burden of Latent Tuberculosis Infection: A Re-estimation Using Mathematical Modelling. PLoS Med. 2016 Oct 25;1
[3](10):e1002152. doi: 10.1371/journal.pmed.1002152. PMID: 27780211; PMCID: PMC5079585.[3] WHO Latent tuberculosis infection: updated and consolidated guidelines for programmatic management 2018, available at URL: https://www.who.int/publications/i/item/9789241550239
[4] World Health Organization, End TB Strategy. Available at URL: https://www.who.int/teams/global-programme-on-tuberculosis-and-lung-health/the-end-tb-strategy
[5] BCG World Atlas, available at URL: http://www.bcgatlas.org/
[6]Elecsys IGRA TB Method Sheet 2026-04 V1.0

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