Targeted next-generation sequencing (NGS) for detecting drug-resistant tuberculosis (TB) represents a novel class of diagnostic technology. It offers a rapid and precise genetic analysis option, detecting mutations associated with resistance much faster than traditional culture-based resistance detection methods. In recent years, various commercially available "End-to-End" tests for targeted NGS have emerged, capable of simultaneously detecting resistance to multiple drugs. These tests provide swift results by directly testing patient samples and have the capability to incorporate new information on genetic markers for resistance as it becomes available.

Innovative diagnostic options for people with drug-resistant TB, such as targeted NGS, are increasing thanks to manufacturer engagement and research generating new evidence," stated Dr. Tereza Kasaeva, Director of WHO’s Global TB Programme. "Ensuring that everyone in need receives a rapid and accurate diagnosis of drug-resistant TB will save lives and reduce suffering."

Detecting all categories of drug-resistant TB remains challenging, necessitating more comprehensive drug susceptibility testing solutions. The rapid introduction of new drugs and the repurposing of existing ones for treating TB and drug-resistant TB have improved treatment options, outcomes, and quality of life for individuals with TB. However, with the gradual increase in resistance to these new and repurposed drugs, enhanced diagnostic methods for the rapid detection of drug-resistant TB are essential.

WHO’s Global TB Programme convened a Guideline Development Group meeting from May 2-5, 2023, to review the available evidence on the use of targeted NGS solutions and to make recommendations on their clinical use in detecting drug-resistant TB.

The Rapid Communication was released ahead of the updated WHO consolidated guidelines for the diagnosis of TB, expected later in 2023, to inform national TB programs and other stakeholders of key changes in the available options for detecting TB drug resistance. This early release aims to facilitate rapid transition and planning at the country level. Further guidance covering practical information on the introduction of sequencing and the updated catalogue of mutations will be announced soon.