Roche secures CE Mark for blood test designed to detect tuberculosis infection

Roche has announced that its Elecsys IGRA TB test has received the CE Mark, bringing a new blood-based testing solution for tuberculosis infection, also known as latent TB, to routine laboratory environments. The solution is designed for fast, straightforward, and efficient diagnosis, with results available in under 24 hours. The Interferon Gamma Release Assay itself completes processing in just 19 minutes per patient, roughly half the time demanded by currently available methods, giving laboratories a faster, more scalable option for tuberculosis infection testing on Roche’s existing platforms.

“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 continues to rank among the most serious public health challenges facing the world, with an estimated 10.7 million people falling ill and 1.23 million losing their lives to the disease in 2024 alone. Roughly a quarter of the global population may carry the bacteria responsible for tuberculosis without knowing it. While the infection can remain dormant and symptom-free for years, between 5 and 10% of cases will advance to active disease over a person’s lifetime. Identifying tuberculosis infection is a fundamental step in interrupting the cycle of progression and transmission, preventing serious health complications, and informing preventive treatment decisions in populations at elevated risk. Broadening access to dependable diagnostics remains essential to meeting the World Health Organization’s global elimination targets, which call for a 90% reduction in tuberculosis deaths and an 80% fall in new cases by 2030.

Blood-based Interferon Gamma Release Assay tests and tuberculin skin tests are both established approaches for identifying tuberculosis infection. Beyond offering greater accuracy and reliability, blood-based testing is less invasive than skin tests, requires only a single patient visit, and lessens reliance on specialist healthcare personnel. Unlike tuberculin skin tests, these assays are minimally affected by Bacillus Calmette-Guérin vaccinations, which remain in widespread use globally.

Conventional Interferon Gamma Release Assay testing has traditionally been constrained by labour-intensive, manual workflows that place a considerable burden on laboratory resources. These demanding processes elevate the risk of errors and create practical barriers for laboratories seeking to adopt more reliable blood-based methods or expand their capacity to meet rising demand for tuberculosis infection diagnostics.

Combining the new Elecsys IGRA TB test with Roche’s existing cobas MTB and cobas MTB-RIF/INH molecular assays gives laboratories an integrated approach to managing both tuberculosis infection and active disease in a single setting. The Elecsys IGRA TB assay will also incorporate a novel digital tool that fully automates result calculation, interpretation, and reporting, ensuring rapid, reliable, and fully traceable outputs while freeing up valuable laboratory capacity. To further ease manual workloads, the assay has been designed for seamless integration with third-party automated liquid handlers for pre-incubation front-end processes. Roche’s longer-term automation roadmap also includes plans for fully integrated proprietary front-end automation, enabling laboratories to improve their workflows now while laying the groundwork for complete end-to-end operational efficiency in the future.

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Related Topics and Keywords

CE Mark, Roche, tuberculosis