Danaher subsidiary Cepheid’s Xpert MTB/XDR assay received World Health Organization prequalification for genotypic detection of resistance to multiple first‑ and second‑line tuberculosis drugs. The designation confirms the test meets WHO standards for quality, safety and performance and allows procurement through international agencies. The cartridge runs on GeneXpert platforms and returns results in about 90 minutes, enabling faster drug‑resistance calls and more timely initiation of appropriate regimens in high‑burden regions. Cepheid emphasized the test’s potential to improve patient outcomes and reduce loss to follow‑up by shortening diagnostic turnaround. WHO prequalification typically accelerates adoption in resource‑limited settings through pooled procurement and donor funding mechanisms, enhancing global TB response capacity.
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