In a significant step toward combating tuberculosis (TB), the World Health Organization (WHO) has granted prequalification to Xpert® MTB/RIF Ultra, a molecular diagnostic test developed by Cepheid Inc. This marks the first TB diagnostic test to meet WHO's rigorous prequalification standards, ensuring quality, safety, and performance.

TB remains a leading global health challenge, claiming over a million lives annually and disproportionately affecting low- and middle-income countries. The emergence of drug-resistant TB has further complicated efforts to curb the disease, making accurate and early detection essential for effective treatment.

“This milestone reflects WHO’s commitment to supporting countries in scaling up access to high-quality TB diagnostic tools,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “It underscores the role of innovative diagnostic solutions in addressing one of the world’s deadliest infectious diseases.”

The Xpert® MTB/RIF Ultra test, designed for the GeneXpert® Instrument System, detects the genetic material of Mycobacterium tuberculosis—the bacterium responsible for TB—directly from sputum samples. The test delivers precise results within hours and identifies mutations linked to rifampicin resistance, a key marker of multidrug-resistant TB. It is specifically intended for patients with suspected pulmonary TB who have not yet started or have had minimal prior treatment.

The WHO prequalification process involved extensive evaluation, including regulatory review by Singapore’s Health Sciences Authority (HSA). The designation assures countries of the test’s quality, paving the way for wider adoption and use in clinical settings.

“High-quality diagnostic tests are the cornerstone of effective TB care and prevention,” emphasized Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification. “Prequalification ensures equitable access to advanced technologies, enabling nations to address both TB and drug-resistant TB.”

This achievement complements WHO’s broader efforts to expand access to quality-assured TB diagnostics. In collaboration with the Global TB Programme and the Department of Regulation and Prequalification, WHO is currently assessing seven additional TB diagnostic tests.

By accelerating the deployment of reliable diagnostic tools like the Xpert® MTB/RIF Ultra, WHO aims to enhance TB detection and treatment, a critical step toward reducing the global burden of this devastating disease.