R2D2-xDRTB - R2D2-XDRTB: Rapid research in next-generation diagnostics development for drug-resistant tuberculosis

Drug-resistant tuberculosis (DR-TB) is a critical global health challenge, particularly in low- and middle-income countries where access to rapid and comprehensive diagnostic testing is limited. Early detection of resistance to first- and second-line TB drugs is critical; however, current WHO-approved low-complexity tools detect only rifampicin resistance, while testing for other drugs requires additional, often inaccessible methods. The rapid emergence of resistance to newer drugs like bedaquiline further limits treatment options, underscoring the urgent need for affordable, scalable, and rapid diagnostics that cover a broader range of drug resistance profiles.
The R2D2-xDRTB project tackles this challenge by accelerating the development, validation, and implementation of next-generation drug susceptibility tests (DSTs). Over 36 months, the project will: (1) conduct multi-centre clinical trials in two high-burden DR-TB countries (South Africa and Georgia) to assess the accuracy of novel DSTs, and (2) integrate multidisciplinary data—including usability, acceptability, feasibility, and cost-effectiveness evaluations—to guide further development and policy. This approach ensures that new diagnostics meet the needs of diverse healthcare systems and end-users while informing implementation strategies.
By leveraging adaptive trial designs, Bayesian analyses, and human factors assessments, R2D2-xDRTB will streamline the validation of both early- and late-stage diagnostic prototypes in parallel, facilitate comparisons, and offer a holistic assessment of the DSTs. The project prioritizes innovative, low-cost, accessible DST solutions to address gaps in resistance detection, improve treatment outcomes, and reduce the global burden of DR-TB. Paired with the capacity strengthening in DR-TB clinical trials, the project represents a critical step toward achieving equitable access to life-saving diagnostics and ending the DR-TB crisis.