Basel, Switzerland, July 9, 2026. Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that its Elecsys IGRA TB test has received the CE Mark.
The test introduces a new blood-based option for identifying tuberculosis infection (TBI), also known as latent TB, in routine laboratory settings.
Laboratories can now access an automated Interferon Gamma Release Assay (IGRA) that delivers results in under 24 hours, with a per-patient processing time of 19 minutes, roughly half the time required by currently used methods.
What The Test Does?
The Elecsys IGRA TB test runs on Roche’s cobas immunoassay systems, which are already widely deployed in clinical laboratories worldwide.
Running the assay on existing cobas infrastructure lets laboratories add tuberculosis infection screening without new hardware investment.
The system automates workflows that traditional IGRA testing typically handles manually, reducing labor demands and cutting the risk of processing errors.
Why Tuberculosis Infection Testing Matters?
Tuberculosis remains a major global health burden. An estimated 10.7 million people fell ill with TB in 2024, and 1.23 million died from the disease that year, including 150,000 among people with HIV, making TB the world’s leading cause of death from a single infectious agent.
Roughly a quarter of the global population is estimated to carry a TB infection, and 5 to 10% of infected individuals will progress to active, symptomatic disease during their lifetime.
The World Health Organization’s End TB Strategy sets a 2030 target of reducing TB incidence by 80% and TB deaths by 90%, compared with 2015 levels. Diagnosing latent infection early allows clinicians to begin preventive treatment before the disease progresses or spreads, which directly supports these elimination goals.
How The Elecsys IGRA TB Test Works?
The assay uses blood samples rather than the tuberculin skin test method that has historically dominated TBI screening. It requires a single patient visit, reduces dependence on specialized staff for administration and follow-up reading, and shows minimal interference from prior Bacillus Calmette-Guérin (BCG) vaccination, a factor that commonly produces false positives on skin tests in populations where BCG vaccination is standard practice.
Roche has built a digital tool into the Elecsys IGRA TB workflow to automate result calculation, interpretation, and reporting, which improves traceability while freeing laboratory staff for other work.
The assay is also designed to integrate with third-party automated liquid handlers for front-end sample processing. Roche has stated that its longer-term automation roadmap includes proprietary front-end automation for fully integrated, end-to-end processing.
Clinical Trial Results
Roche evaluated the Elecsys IGRA TB test in a multi-center study spanning low-incidence and high-incidence settings across the European, Western Pacific, African, and Americas regions.
Among individuals who required tuberculosis infection testing as part of routine clinical care, the test achieved a positive percent agreement of 91.12% and a negative percent agreement of 94.57% against standard-of-care methods.
In patients with bacteriologically confirmed active TB disease, the test showed 100% relative sensitivity compared with an established IGRA method. In a low-risk cohort assessed under standard clinical trial protocol, the test demonstrated 95.32% specificity.
Integration With Existing Diagnostics
Laboratories that pair the Elecsys IGRA TB test with Roche’s molecular cobas MTB and cobas MTB-RIF/INH assays gain a combined solution covering both latent infection and active disease detection.
This pairing allows a single laboratory workflow to address the full diagnostic pathway, from identifying infection risk to confirming active disease and detecting drug resistance.
Executive Statement
Matt Sause, CEO of Roche Diagnostics, said addressing latent tuberculosis requires better and more accessible testing to reduce the disease’s global health burden.
He said the Elecsys IGRA TB test brings automation to latent TB detection on Roche’s immunoassay platforms, which he expects will support screening programs and progress toward global TB elimination targets.
About Roche
Roche is a healthcare company operating across diagnostics, medicines, and digital health solutions. Founded in Basel, Switzerland in 1896, Roche now provides diagnostics and medicines in more than 150 countries.
The company’s work spans oncology, neurology, cardiovascular and metabolic disease, ophthalmology, infectious disease, and immunology. Genentech operates as a wholly owned Roche subsidiary in the United States, and Roche holds a majority stake in Chugai Pharmaceutical, a leading therapeutic antibody developer in Japan.
