Cepheid has announced that it has received a medical device licence from Health Canada for its Xpert® HIV-1 Viral Load XC test—a next-generation, extended-coverage (XC) assay developed to support monitoring of HIV viral load and the effectiveness of antiretroviral therapy (ART).
The Xpert® HIV-1 Viral Load XC test uses dual-target technology to broaden strain coverage, delivering reliable performance with a streamlined workflow. This advancement aims to expand access to high-quality HIV care, supporting progress toward the UNAIDS 2030 HIV targets.
“By utilizing dual-target technology, the Xpert® HIV-1 Viral Load XC test enhances detection while offering the flexibility of on-demand testing with results available in as little as 90 minutes,” said Vitor Rocha, President of Cepheid. “Faster access to accurate viral load data can significantly improve patient management by informing treatment decisions and enabling earlier therapeutic intervention and counseling.”
The test is compatible with all Cepheid GeneXpert® Systems, allowing real-time PCR testing to be performed not only in traditional lab settings but also in community clinics and physician offices.
Shipments of Xpert® HIV-1 Viral Load XC to customers in Canada are scheduled to begin in June 2025.