NEW YORK – The World Health Organization on Thursday announced that it has granted prequalification to a molecular diagnostic test for tuberculosis made by Danaher subsidiary Cepheid.
The Xpert MTB/RIF Ultra test is the first assay for tuberculosis diagnosis and antibiotic susceptibility testing that meets WHO's prequalification standards, the organization said in a statement. WHO prequalification assures the quality of diagnostic tests that are used to improve access to early diagnosis and treatment. The organization's prequalification assessment is based on information submitted by Cepheid and a review by Singapore's Health Sciences Authority, which is the regulatory agency of record for the product, the WHO said.
"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," Yukiko Nakatani, WHO's assistant director-general for access to medicines and health products, said in a statement. "It underscores the importance of such groundbreaking diagnostic tools in addressing one of the world's deadliest infectious diseases."
The real-time PCR test detects the genetic material of Mycobacterium tuberculosis in sputum samples and runs on Cepheid's GeneXpert platform. The test also identifies mutations associated with rifampicin resistance, which indicates multidrug-resistant tuberculosis.
It is intended for use in patients who screen positive for pulmonary tuberculosis and either have not started anti-tuberculosis treatment or received less than three days of therapy in the prior six months.
WHO is currently assessing seven additional tuberculosis tests for prequalification.
Cepheid and its parent company Danaher recently faced calls from Doctors Without Borders/Médecins Sans Frontières to lower the price of its tuberculosis test to $5.00 to improve access to the assay. In 2023, Danaher announced it would provide the test at cost for $7.97 to the Global Fund to Fight AIDS, TB, and Malaria, as well as to less-developed countries eligible for Cepheid's Global Access Program.