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

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).

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.