Cepheid Announces WHO Prequalification of the Xpert® MTB/XDR Test

28 October 2025

SUNNYVALE, Calif., Oct. 28, 2025 — Cepheid announced that its Xpert^® MTB/XDR test has been awarded prequalification status by the World Health Organization (WHO), marking a new milestone in the global fight against TB. This designation affirms the test’s compliance with the WHO’s rigorous standards for quality, safety, and performance, and enables procurement through international agencies.

Xpert MTB/XDR is designed to detect resistance to multiple first- and second-line TB drugs — including isoniazid, ethionamide, fluoroquinolones, amikacin, kanamycin, and capreomycin — directly from patient specimens. According to the WHO Consolidated Guidelines on Tuberculosis, fast and accurate testing is an essential step in the pathway of TB care. The guidelines note, “introduction of this test is likely to result in faster time to a result for genotypic DST [drug susceptibility testing] and could affect cost–effectiveness by improving the numbers of patients initiating treatment, reducing loss to follow-up and improving survival rates.” According to WHO, patients in high burden TB settings value getting an accurate diagnosis, reaching diagnostic closure, and avoiding diagnostic delays “because they [delays] exacerbate existing financial hardships and emotional and physical suffering”.

Read the full company press release here.

Source: Cepheid