Roche has received the CE Mark for its Elecsys Interferon Gamma Release Assay TB test, a blood-based diagnostic for identifying tuberculosis infection in routine laboratory settings. The new solution provides rapid, high-throughput, and cost-effective testing, delivering reliable results in under 24 hours with a processing time of just 19 minutes per patient, approximately half the time of currently used methods. In a global multi-centre study, the test achieved 91.12% positive per cent agreement and 94.57% negative per cent agreement compared to standard of care methods, and demonstrated 100% relative sensitivity among bacteriologically confirmed TB patients. The assay includes a digital tool for fully automated result calculation, interpretation, and reporting, and is designed to integrate with third-party automated liquid handlers. Roche Diagnostics CEO Matt Sause stated that the test brings an automated solution for latent TB, supporting the World Health Organisation's targets to decrease tuberculosis deaths by 90% and new cases by 80% by 2030.
Roche Holding AGRoche received CE Mark for a new TB diagnostic test with superior performance and automation.