First TB Molecular Diagnostic Test Granted WHO Prequalification

Tuberculosis (TB) is one of the most deadly infectious diseases globally, responsible for over a million deaths each year and imposing significant socioeconomic challenges, particularly in low- and middle-income countries. The early and accurate detection of TB, particularly drug-resistant strains, remains a critical and difficult global health concern. Now, a new diagnostic test for TB and antibiotic susceptibility has become the first to meet the World Health Organization's (WHO) prequalification standards, improving access to timely diagnosis and treatment.

Cepheid’s (Sunnyvale, CA, USA) molecular diagnostic test for TB called Xpert MTB/RIF Ultra has been granted prequalification by the WHO, making it the first test for TB diagnosis and antibiotic susceptibility testing to meet WHO's prequalification standards. The test, designed for use on the GeneXpert Instrument System, is a nucleic acid amplification test (NAAT) that detects the genetic material of Mycobacterium tuberculosis, the bacterium responsible for TB, from sputum samples and delivers results in just hours. Additionally, the test identifies mutations associated with rifampicin resistance, which is a key marker of multidrug-resistant TB. It is specifically intended for patients who screen positive for pulmonary TB and have either not started anti-tuberculosis treatment or have received less than three days of therapy in the past six months.

The WHO prequalification of this test is expected to guarantee the quality of diagnostic tools, helping to enhance early diagnosis and treatment accessibility. It supports the WHO’s endorsement approach, which is based on emerging evidence, diagnostic accuracy, patient outcomes, and the emphasis on accessibility and equity, with prequalification focusing on quality, safety, and performance. WHO’s prequalification process for this test was based on data provided by Cepheid and a review by Singapore’s Health Sciences Authority (HSA), the product’s regulatory body.

“This first prequalification of a diagnostic test for tuberculosis marks a critical milestone in WHO’s efforts to support countries in scaling up and accelerating access to high-quality TB assays that meet both WHO recommendations and its stringent quality, safety, and performance standards,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “It underscores the importance of such groundbreaking diagnostic tools in addressing one of the world's deadliest infectious diseases.”

“High-quality diagnostic tests are the cornerstone of effective TB care and prevention,” added Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification. “Prequalification paves the way for equitable access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB.”

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