Roche receives CE Mark for blood test to identify tuberculosis infection
Friday, July 10, 2026
Roche has received CE Mark approval for its Elecsys IGRA TB test, expanding its tuberculosis (TB) diagnostics portfolio with a new blood test designed to identify tuberculosis infection (TBI), also known as latent TB, in routine laboratory settings.
The test enables laboratories to diagnose tuberculosis infection quickly and efficiently, with results available in less than 24 hours. The Interferon Gamma Release Assay (IGRA) takes around 19 minutes per patient, reducing processing time by about half compared with many existing methods. This allows laboratories to improve turnaround times while supporting higher testing volumes on Roche’s diagnostic systems.
Tuberculosis remains a major global health challenge. In 2024, an estimated 10.7 million people developed the disease and around 1.23 million died from it. Approximately one-quarter of the world's population is believed to have been infected with the bacteria that cause TB. Although many infections remain dormant without symptoms, around 5% to 10% of infected people may develop active tuberculosis during their lifetime. Early detection of latent TB is important to prevent disease progression, reduce transmission and support preventive treatment in high-risk groups. Improved access to reliable testing also supports the World Health Organization’s target of significantly reducing TB cases and deaths by 2030.
Blood-based IGRA tests and tuberculin skin tests are both used to detect tuberculosis infection. Compared with skin tests, IGRAs generally offer greater accuracy, require only one patient visit and are less affected by Bacillus Calmette-Guérin (BCG) vaccination. They also reduce the need for specialised healthcare staff.
Conventional IGRA testing often relies on labour-intensive manual procedures, increasing laboratory workload and the possibility of errors. These limitations can make it more difficult for laboratories to expand testing capacity or adopt blood-based TB diagnostics.
The Elecsys IGRA TB test can be used alongside Roche’s cobas MTB and cobas MTB-RIF/INH molecular assays, providing laboratories with an integrated solution for detecting both latent tuberculosis infection and active disease. The assay also includes a digital tool that automates result calculation, interpretation and reporting, helping laboratories deliver fast, reliable and fully traceable results while reducing manual work.
In addition, the assay is designed to integrate with third-party automated liquid handling systems for sample preparation before tube incubation. Roche also plans to introduce its own fully integrated front-end automation in the future, allowing laboratories to further improve workflow efficiency and move towards end-to-end automated tuberculosis testing.
Source: globenewswire.com
