WHO prequalifies diagnostic test for drug-resistant TB

GENEVA: The first diagnostic and antibiotic susceptibility test -- Xpert® MTB/RIF Ultra -- a molecular diagnostic test for tuberculosis (TB), has been prequalified by the World Health Organization for meeting its standards.
Tuberculosis remains a leading infectious disease, claiming over a million lives annually and placing heavy socioeconomic burdens on low- and middle-income countries. Early and accurate detection, particularly of drug-resistant TB strains, is critical to combatting the disease.
“This milestone underscores WHO’s commitment to accelerating access to high-quality TB diagnostics,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Innovative tools like this are vital to addressing one of the world’s deadliest infectious diseases.”
The test, developed by Cepheid Inc., is designed for use with the GeneXpert® Instrument System. It detects the genetic material of Mycobacterium tuberculosis in sputum samples within hours, while also identifying mutations linked to rifampicin resistance—a key marker of multidrug-resistant TB.
The test is intended for patients with suspected pulmonary TB who have not started treatment or have received less than three days of therapy in the past six months.
WHO’s prequalification process, based on evidence submitted by the manufacturer and reviewed by Singapore’s Health Sciences Authority (HSA), ensures the quality, safety, and performance of diagnostic tools. The approval complements WHO’s broader strategy to promote accessibility and equity in TB diagnostics.
Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification, highlighted the significance of the development: “High-quality diagnostics are the cornerstone of effective TB care. Prequalification ensures equitable access to cutting-edge technologies, enabling countries to tackle TB and drug-resistant TB more effectively.”
In a joint effort, WHO’s Global TB Programme and the Department of Regulation and Prequalification are working to expand diagnostic options globally. The organisation is currently evaluating seven additional TB diagnostic tests to further enhance access and treatment outcomes.