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Eliminating tuberculosis by expanding molecular diagnostics

As tuberculosis continues to place a significant healthcare and socioeconomic burden on the world, the World Health Organization (WHO) has pushed the need for increasing the availability of molecular diagnostics to help eliminate the epidemic by 2030. Mycobacterium tuberculosis (TB) is the leading cause of infectious disease deaths worldwide. In 2019, TB infected about 1.7 billion people, with an estimated 10 million new cases and 1.4 million deaths reported.1 This includes approximately 815,000 tuberculosis infections in people living with HIV/AIDS and 208,000 deaths in this population.1

Progress has been made toward the 2030 targets but diagnostic challenges remain and acceleration is needed to reach the TB-elimination goals. COVID-19 hindered progress as funding and healthcare resources were re-allocated to help fight the pandemic. To reach these TB-elimination goals, healthcare agencies, national governments and other stakeholders have emphasized the need for innovative diagnostics so clinicians can receive the information they need to properly diagnose infections, improve treatment access and reduce disease transmission.

End TB Strategy1

End TB strategy Graph
Value of TB diagnostics

According to the WHO, “there is an ongoing need to scale-up capacity to test larger numbers of specimens” if the world is to reach its goal of eliminating TB by 2030.2 High-throughput molecular platforms that accommodate multiple disease-specific tests proved beneficial during the COVID-19 pandemic and can help TB programs globally. Combining the correct diagnostic methods that are highly efficient and cost-effective in the right patient setting can increase access, guide treatment decisions and improve quality of life.

 

With resource-limited countries reliant on WHO guidance to implement TB diagnostics that meet a certain quality standard, the WHO convened a Guidelines Development Group (GDG) meeting in December 2020 to update its diagnostic guidelines on the use of nucleic acid amplification tests (NAATs) to detect TB and resistance to selected anti-TB agents.2 By increasing the number of reliable molecular diagnostic tests available for TB programs in high-burden regions, the update enables Roche to provide its diagnostic solutions in low- and middle-income countries (LMIC’s).

Eliminating Tuberculosis
Roche’s commitment to TB molecular diagnostics

Roche’s Global Access Program was established to address the challenge of universal access to quality healthcare and medical innovation. In 2019, the Program was expanded to include tuberculosis diagnostic solutions. This enables LMIC’s to obtain high-quality tests at an affordable price, thereby allowing clinicians to diagnose more patients promptly.

Roche understands the need for taking a holistic diagnostic approach that ensures validated test results are accessible in LMIC’s to battle this healthcare challenge. To accelerate these efforts, the company is supporting current TB program strategies and eradication in urban settings with a systems integration approach through multi-disease diagnostics. Creating centralized diagnostic hubs supports not only scaling TB program capacity but also enabling capacity for future pandemics.

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Roche has developed TB diagnostic solutions that can aid healthcare systems in improving health outcomes in high-burden regions and ensure patients get suitable treatment regimens. Its automated, highly-sensitive in vitro diagnostic test detects TB infection, while the rapid drug resistance test detects anti-TB treatment resistance, specifically mutations associated with Rifampicin-resistance and Isoniazid-resistance. Roche is also working on a patient-centric disease management digital solution that educates patients about TB infections, closes the gap on patient follow-up and ensures adherence to TB treatment regimen through reminders directly delivered to a patient’s mobile device.

A reliable and accurate diagnosis for TB reduces the risk of further transmission, delays in treatment and additional healthcare and socioeconomic system burdens. It is part of Roche’s commitment to improving access to innovative products and services by the people who need them, when they need them – no matter where they live.

References

  1. Global tuberculosis report 2020. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO.
  2. Update on the use of nucleic acid amplification tests to detect TB and drug-resistant TB: rapid communication. Geneva: World Health Organization; 2021. Licence: CC BY-NC-SA 3.0 IGO.