Cepheid Announces World Health Organization Prequalification of the Xpert® MTB/XDR test

Expanding Global Access to Diagnostics for Drug-Resistant Tuberculosis

SUNNYVALE, Calif., Oct. 28, 2025 /PRNewswire/ -- Cepheid today 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 tuberculosis (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.^1,2

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,³ 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."³ According to the 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".³

Cepheid has supported TB testing worldwide for over 15 years. Xpert MTB/RIF, released in 2009 in collaboration with the Foundation for Innovative New Diagnostics (FIND), was a first-of-its-kind molecular test that could simultaneously detect Mycobacterium tuberculosis (the bacterium that causes TB) and potential resistance to rifampin, a first-line TB drug. Cepheid continued to invest in improving TB diagnostics in collaboration with FIND and Rutgers New Jersey Medical School starting in 2014.⁴ The resulting second-generation test, Xpert MTB/RIF Ultra, was released in 2017, followed by Xpert MTB/XDR in 2020. Xpert MTB/RIF Ultra was the first test for TB diagnosis and antibiotic susceptibility testing to meet WHO's prequalification standards,⁵ setting a benchmark for quality and reliability.

With this new prequalification, Cepheid reinforces its leadership in TB diagnostics and its dedication to improving global health outcomes with tests that meet the most rigorous global standards. Vitor Rocha, President of Cepheid, remarked, "Cepheid is committed to advancing diagnostic innovation in the fight against tuberculosis. This test equips healthcare providers with fast, reliable insights into drug resistance, potentially enabling more precise treatment decisions and improving patient outcomes—especially in high-burden regions where timing and accuracy are critical."

The Xpert MTB/XDR test runs on Cepheid's GeneXpert^® systems equipped with 10-color multiplexing technology, delivering results in about 90 minutes. GeneXpert systems can be deployed to a wide range of healthcare environments, including decentralized and remote locations—bringing advanced molecular diagnostics directly to the front lines of TB care.

Xpert MTB/XDR joins a comprehensive portfolio of WHO prequalified Xpert tests available internationally, including Xpert MTB/Rif Ultra, Xpert HIV-1 Qual XC, Xpert HIV-1 Viral Load, Xpert HBV Viral Load, Xpert HCV Viral Load, Xpert HCV VL Fingerstick, and Xpert HPV. 

For more information on Cepheid's GeneXpert systems or the complete menu of Xpert tests, visit www.cepheidinternational.com. 

CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries. Not available in the United States.

References:

1. Technical Guidance Series for WHO Prequalification – Diagnostic Assessment: Establishing stability of in vitro diagnostic medical devices. Geneva: World Health Organization; 2018 License: CC BY-NC-SA 3.0 IGO. https://iris.who.int/handle/10665/272807 Accessed October 22, 2025.
2. WHO. Collaborative registration procedure for prequalified in vitro diagnostics. https://www.who.int/teams/regulation-prequalification/regulation-and-safety/facilitated-product-introduction/collaborative-registration-procedure/crp-for-who-prequalified-in-vitro-diagnostics Accessed October 22, 2025.
3. WHO consolidated guidelines on tuberculosis. Module 3: diagnosis – rapid diagnostics for tuberculosis detection, third edition. Geneva: World Health Organization; 2024. License: CC BY-NC-SA 3.0 IGO.
4. FIND Joint Press Release. Cepheid, FIND & Rutgers announce collaboration for next-generation innovations to game-changing Xpert MTB/RIF test. 28 October, 2014. Accessed October 23, 2025.
5. WHO Press Release. WHO announces first prequalification of a tuberculosis diagnostic test. 5 December, 2024. https://www.who.int/news/item/05-12-2024-who-announces-first-prequalification-of-a-tuberculosis-diagnostic-test. Accessed October 23, 2025

About Cepheid

Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert^® systems and Xpert^® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid's broad test portfolio spans respiratory infections, blood virology, women's and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company's solutions deliver actionable results where they are needed most—from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

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