Roche has received CE Mark certification for its Elecsys IGRA TB test, a new blood-based diagnostic designed to identify tuberculosis infection, also known as latent tuberculosis, in routine laboratory settings.
The test is intended to provide laboratories with a faster and more automated option for interferon gamma release assay, or IGRA, testing. Roche said the overall solution can deliver results in under 24 hours, while the assay itself requires approximately 19 minutes of processing time per patient. According to the company, this is about half the time required by currently used IGRA methods.
The CE Mark allows the test to be marketed in applicable European markets and represents an important step in expanding access to blood-based testing for tuberculosis infection. The assay will run on Roche’s immunoassay platforms and is designed to support laboratories that need scalable testing capacity and shorter turnaround times.
Tuberculosis remains a major global public health concern. Roche cited estimates that 10.7 million people developed tuberculosis disease in 2024 and 1.23 million people died from the illness. An estimated one-quarter of the global population may have been infected with the bacteria that cause tuberculosis, although many people do not develop active disease immediately.
In latent tuberculosis infection, the bacteria remain dormant in the body and do not cause symptoms. However, an estimated 5% to 10% of infected individuals may progress to active tuberculosis during their lifetime. Identifying infection in high-risk populations can help guide preventive treatment and reduce the risk of disease progression and transmission.
Interferon gamma release assays and tuberculin skin tests are commonly used to detect tuberculosis infection. IGRA tests require a blood sample and generally involve a single patient visit, unlike skin tests, which typically require patients to return for interpretation. IGRAs are also less affected by prior Bacillus Calmette-Guérin vaccination, which is widely used in many countries to prevent severe forms of tuberculosis.
Roche said traditional IGRA workflows can be labor-intensive and often require manual handling, which may increase the risk of errors and limit laboratories’ ability to expand testing capacity. The Elecsys IGRA TB test is designed to reduce these burdens through automation and digital result management.
The assay will include a digital tool intended to automate result calculation, interpretation and reporting. Roche said this feature could help laboratories produce traceable results while reducing administrative and technical workload.
The company also plans to support integration with third-party automated liquid handlers for front-end processes before tube incubation. In the longer term, Roche expects to introduce proprietary front-end automation to create a more fully integrated workflow.
Roche said the Elecsys IGRA TB test can be used alongside its cobas MTB and cobas MTB-RIF/INH molecular assays, allowing laboratories to manage testing for both latent tuberculosis infection and active tuberculosis disease through a broader diagnostic portfolio.
The launch supports wider efforts to meet World Health Organization targets to reduce tuberculosis deaths by 90% and new cases by 80% by 2030.