Hepatitis C Assay Receives European In Vitro Diagnostic Test Certification

Laboratories that adhere to the European Directive on In Vitro Diagnostic Medical Devices will now be able to work with a quantitative test that provides on-demand molecular testing for confirmation of infection and monitoring of Hepatitis C virus (HCV).

The Cepheid (Sunnyvale, CA, USA) Xpert HCV Viral Load assay was recently awarded CE IVD mark status under the European Directive. The test was designed to run on the Cepheid GeneXpert System, one of the world's leading molecular diagnostic platforms with over 8,000 systems deployed globally in both developed and emerging market countries.


Cepheid's GeneXpert System is a closed, self-contained, fully-integrated, and automated platform that combines on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples.

The Xpert HCV Viral Load assay is intended for use as an aid in the management of HCV infected patients undergoing antiviral therapy. The test can be used to measure HCV RNA levels at baseline and during treatment, and to help predict virological responses to HCV therapy. In addition, the test can be used for confirmation of HCV serologic test results.

"Existing HCV viral load tests run on complex systems that require highly-trained technicians to operate, and generally lack the flexibility to provide on-demand answers when required," said John Bishop, chairman and CEO of Cepheid. "Xpert HCV Viral Load, our 21st CE-IVD Xpert test, provides reliable results in less than two hours, making it a valuable tool for clinicians in the management of HCV infected patients on antiviral therapy."

"The Xpert HCV Viral Load test incorporates a number of novel technologies including our "BigTube" design, which allows us to take full advantage of the efficiency of integrated GeneXpert cartridge fluidics," said Dr. David H. Persing, CMO and CTO at Cepheid. "This helps us to avoid dead volume losses incurred with competitive first generation systems and to achieve unprecedented sensitivity levels for detection of HCV RNA."

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