Roche Gains CE Mark for Elecsys IGRA TB Blood Test on cobas Immunoassay Platform

Roche's Elecsys IGRA TB test has secured the CE Mark, giving laboratories across CE-registered markets an automated, high-throughput option for tuberculosis infection (TBI) identification that runs on the company's existing cobas immunoassay infrastructure, a development with direct implications for QA directors evaluating IVD workflow integration and validation scope.

The assay is an Interferon Gamma Release Assay (IGRA) that processes each patient sample in 19 minutes, roughly half the cycle time of currently established IGRA methods, with full results available in under 24 hours. Unlike tuberculin skin tests, the blood-based format requires a single patient visit and shows minimal interference from BCG vaccination, reducing a known confounding variable in high-prevalence screening programs.

For laboratory operations teams, the more consequential element may be the embedded digital tool that automates result calculation, interpretation, and reporting end-to-end. Fully traceable outputs reduce manual transcription risk and align with 21 CFR Part 11-equivalent electronic records expectations under EU IVDR audit frameworks. Laboratories already running cobas molecular assays, including cobas MTB and cobas MTB-RIF/INH, can position the Elecsys IGRA TB test as a complementary layer covering latent infection alongside active disease detection, without introducing a separate instrument platform.

The regulatory backdrop is relevant context. CE Mark under the EU In Vitro Diagnostic Regulation signals conformity assessment against performance and quality management requirements that increasingly mirror ICH Q10 principles for systematic process control. QA directors overseeing IVD procurement will need to account for method validation, reference range establishment, and CAPA documentation as part of any site-level implementation plan.

Tuberculosis remains a substantial public health burden: the WHO recorded 10.7 million new cases and 1.23 million deaths in 2024, with an estimated quarter of the global population carrying latent infection. The WHO's 2030 elimination targets, a 90% reduction in TB deaths and 80% reduction in new cases, depend materially on scaling latent infection detection in routine laboratory settings, the precise gap this platform targets.

Successful integration across high-volume screening programs will serve as the measurable checkpoint for whether automated IGRA throughput translates into the population-level detection rates the WHO elimination framework requires.

Source: Roche via GlobeNewswire, 9 July 2026.