Roche wins CE Mark for automated blood test for latent TB

Roche has received CE Mark approval for its Elecsys IGRA TB test, a blood-based assay for identifying tuberculosis infection (TBI), commonly known as latent TB. The Basel-headquartered diagnostics and pharmaceuticals group said the test is designed to run on its widely deployed cobas immunoassay systems, enabling laboratories to automate IGRA workflows and deliver results in under 24 hours. The assay itself processes each patient sample in 19 minutes, which the company says is roughly half the time required by existing methods.

The approval adds a regulatory milestone to Roche Diagnostics' infectious-disease portfolio and addresses a known bottleneck in global TB control programmes: the labour-intensive manual workflows that have historically limited the uptake of blood-based IGRA testing in high-volume laboratory settings.

Clinical performance

In a multi-centre global study conducted across low- and high-incidence settings spanning European, Western Pacific, African and American regions, the Elecsys IGRA TB test achieved a positive percent agreement of 91.12% and a negative percent agreement of 94.57% against standard-of-care methods in the intended-use population. In patients with bacteriologically confirmed TB disease, the assay showed 100% relative sensitivity compared to an established IGRA comparator, and a specificity of 95.32% in a low-risk cohort. Roche said these figures together demonstrate reliable performance across diverse settings.

Matt Sause, chief executive of Roche Diagnostics, said the test "brings an automated solution for latent TB to Roche's industry-leading immunoassay platforms, which will enable screening programmes and drive significant progress toward achieving global TB elimination targets."

The release notes a companion digital tool to automate result calculation, interpretation and reporting, as well as integration with third-party automated liquid handlers for front-end sample preparation. Roche said its longer-term roadmap includes fully proprietary front-end automation, though no timeline was given for that capability.

Market context and regulatory backdrop

Tuberculosis remains a major global public health challenge. According to the WHO Global Tuberculosis Report 2025, an estimated 10.7 million people fell ill with TB and 1.23 million died from it in 2024. Roughly a quarter of the world's population is thought to carry latent TB infection, of whom 5 to 10% may progress to active disease over their lifetime. The WHO's End TB Strategy calls for a 90% reduction in TB deaths and an 80% reduction in new cases by 2030, targets that remain ambitious given current diagnostic coverage gaps.

CE Mark approval gives Roche access to markets across the European Economic Area and a number of reference jurisdictions beyond. The company is positioning the Elecsys IGRA TB test as complementary to its existing molecular portfolio, including the cobas MTB and cobas MTB-RIF/INH assays for active disease detection, creating an integrated TB diagnostic pathway on a single platform.

In the broader IGRA market, Roche competes with a small number of established players, most notably Oxford Immunotec, now part of PerkinElmer, which markets the T-SPOT.TB test. The competitive advantage Roche is pointing to is throughput automation on infrastructure that many hospital and reference laboratories already operate, which could lower the switching cost for large-volume testing sites. Whether this translates into meaningful market share gains will depend on pricing and reimbursement dynamics in key markets, including procurement frameworks under EU public health programmes and national TB control budgets in higher-burden settings.