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Roche Secures CE Mark for Automated Blood Test to Detect Latent Tuberculosis

  • 作家相片: nuaxia
    nuaxia
  • 1天前
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The Elecsys IGRA TB test delivers results in under 24 hours and brings automated latent tuberculosis screening to Roche's cobas immunoassay platforms. Roche has received CE Mark approval for its Elecsys Interferon Gamma Release Assay (IGRA) TB test, a blood-based diagnostic designed to detect latent tuberculosis infection (TBI) in routine laboratory settings.

The automated assay is designed to improve testing efficiency by running on Roche's cobas immunoassay systems, helping laboratories increase throughput while reducing manual workflows.

Faster, Automated TB Screening

The Elecsys IGRA TB test delivers results in less than 24 hours, with each assay requiring approximately 19 minutes to process.

By integrating automated sample handling and digital workflows, the system is intended to support growing demand for latent tuberculosis screening while improving laboratory efficiency.

Roche says the platform offers faster turnaround times and greater testing capacity compared with traditional manual testing methods.

Supporting Global Tuberculosis Control

Latent tuberculosis occurs when individuals are infected with Mycobacterium tuberculosis but do not show symptoms of active disease.

Without diagnosis and treatment, latent infection can later progress to active tuberculosis, contributing to ongoing disease transmission and mortality.

The World Health Organization (WHO) has identified improved diagnosis and treatment of latent TB as a key component of its strategy to reduce tuberculosis deaths by 90% and new cases by 80% by 2030.

Roche believes wider access to automated diagnostics could help support these global elimination efforts.

Clinical Study Demonstrates Strong Performance

The CE Mark approval was supported by a global multi-centre clinical evaluation conducted across regions with both high and low tuberculosis incidence, including Europe, Africa, the Western Pacific and the Americas.

Compared with existing standard testing methods, the Elecsys IGRA TB assay demonstrated:

  • 91.12% positive percent agreement

  • 94.57% negative percent agreement

  • 100% relative sensitivity in patients with bacteriologically confirmed tuberculosis

  • 95.32% specificity in a low-risk patient cohort

The findings indicate the assay can accurately identify latent tuberculosis infection while maintaining strong diagnostic performance across diverse populations.

Expanding Roche's Diagnostics Portfolio

The approval further strengthens Roche's diagnostics business as the company continues to invest in laboratory automation and molecular testing technologies.

It follows the recent launch of Axelios 1, Roche's next-generation sequencing platform for research applications, reflecting the company's continued focus on expanding its diagnostic capabilities.

Why the CE Mark Matters

The approval highlights several important trends across diagnostic medicine:

  • Automated laboratory testing is helping improve efficiency and scalability for infectious disease screening.

  • Early identification of latent tuberculosis remains central to global disease elimination strategies.

  • Blood-based diagnostics are increasingly replacing more labour-intensive testing workflows.

  • Integrated laboratory platforms continue to play a growing role in public health screening programmes.

Summary

Roche has secured CE Mark approval for its Elecsys IGRA TB blood test, providing laboratories with an automated solution for detecting latent tuberculosis infection.

Designed for use on Roche's cobas immunoassay systems, the assay delivers rapid, high-throughput testing and supports global efforts to improve tuberculosis screening and reduce the burden of one of the world's leading infectious diseases.

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