Cepheid Receives Health Canada Licence for Xpert® HCV VL Fingerstick

Detection and quantitation of Hepatitis C virus (HCV) in about an hour

SUNNYVALE, Calif. , Aug. 19, 2025 /CNW/ -- Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert^® HCV VL Fingerstick, an HCV RNA test that detects and quantifies HCV directly from a drop of blood, simplifying the diagnostic pathways to speed up linkage to care and monitoring sustained virological response. Xpert HCV VL Fingerstick test is performed on the GeneXpert^® system.

Xpert® HCV VL Fingerstick

There is no vaccine for hepatitis C, but it can be treated and cured with antiviral medications. The Health Infobase estimates that over 200,000 people are living with chronic hepatitis C in Canada.¹ Globally, more than half of people with HCV do not know that they have the virus. 

"Timely diagnosis is key to identifying and treating people with hepatitis C. Point-of-care tests allow us to diagnose people wherever they are, without necessarily needing them to come to traditional health care facilities. This can be hugely impactful, particularly for those who do not have equitable access to health care, such as people who use drugs and people in remote settings," said Dr. Jordan Feld, Director of the Toronto Centre for Liver Disease and Professor of Medicine at the University of Toronto. "To reach the World Health Organization's goal of eliminating HCV by 2030, we need to find and diagnose those living with HCV and get them access to care and treatment. Point-of-care tests make that much more feasible."

"This simple to use test detects the full range of known HCV genotypes in about an hour and can be performed on a small volume of blood collected via fingerstick," said Vitor Rocha, President of Cepheid. "This is the first HCV RNA detection and quantification technology sensitive enough for active case finding at the point of care in Canada. This enables diagnosis of HCV and facilitates timely linkage to care within a single clinic visit — and with this, the potential for treating more people with HCV."

The test is designed for use on Cepheid's GeneXpert system which provides 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® HCV VL Fingerstick will begin shipping to customers in Canada in August 2025.

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

1.  https://health-infobase.canada.ca/hepatitis-c-treatment/  Accessed July 2025

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