Cepheid Receives Health Canada Licence for Xpert® HIV-1 Viral Load XC

Next-Generation Molecular Test for Monitoring Viral Load and HIV-1 Infection

SUNNYVALE, Calif., June 4, 2025 /CNW/ -- Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert^® HIV-1 Viral Load XC, a next-generation extended-coverage (XC) test intended to aid in assessing HIV viral load levels, which are used to monitor effectiveness of antiretroviral treatment.

Xpert^® HIV-1 Viral Load XC dual target test provides extended strain coverage ensuring a high level of performance with a simple workflow to improve patient access to the standard of care and help achieve UNAIDS HIV targets by 2030.¹  

"Xpert^® HIV-1 Viral Load XC leverages dual target technology to improve detection while maintaining the flexibility to be performed on-demand in as little as 90 minutes." said Vitor Rocha, President of Cepheid. "Access to the test can enhance patient care, as measurement of HIV viral load informs treatment plans while fast results enable earlier interventions with counseling and therapy."

The test is designed for use on any of Cepheid's GeneXpert^® Systems which provide simple, reference lab quality PCR testing on location in laboratory environments at medical centers and hospitals or in community health clinics and physician offices. 

Xpert^® HIV-1 Viral Load XC will begin shipping to customers in Canada in June 2025.

Visit https://www.cepheid.com/en_CA  for more information.

1. Malisa et al 2023 Nature Scientifc Reports | (2023) 13:4578
   https://doi.org/10.1038/s41598-023-31103-y 

About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.

IVD. In Vitro Diagnostic Medical Device. May not be available in all countries

For Cepheid Media Inquiries:
Darwa Peterson
[email protected] 

SOURCE Cepheid