Cepheid Announces European Approval of Xpert HCV Viral Load

Cepheid

today announced that Xpert® HCV Viral Load, a quantitative test that provides on-demand molecular testing for confirmation of infection and monitoring of Hepatitis C virus (HCV), has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices. The test runs on the Cepheid GeneXpert® System, the world's leading molecular diagnostic platform with over 8,000 systems deployed globally in both developed and emerging market countries. The objective of treatment for HCV is for a patient to have sustained virologic response, defined as undetectable HCV RNA by a sensitive test 12 or 24 weeks after the end of treatment, depending on the type of anti-HCV therapy used.1 Xpert HCV Viral Load 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 sustained and nonsustained 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, Cepheid's Chairman and Chief Executive Officer. "Xpert HCV Viral Load, our 21st CE-IVD Xpert test, provides reliable results in less than 2 hours, making it a valuable tool for clinicians in the management of HCV infected patients on antiviral therapy." An estimated 185 million people, or roughly 3% of the world's population, have been infected with HCV. Most of these people are unaware of their infection.2 "Cepheid's Xpert HCV Viral Load test delivers results in hours rather than days — with the simplicity and ease of use of a point-of-care test. It is a very sensitive test for confirmation of infection and monitoring of HCV, and will assist in better patient management," said Dr. Jean-Michel Pawlotsky M.D., Ph.D., Professor of Medicine at the University of Paris-Est, and Director of the National Reference Center for Viral Hepatitis B, C and Delta, Director of the Department of Virology at the Henri Mondor University Hospital in Créteil, France, and Director of the Department of Molecular Virology and Immunology at the Institut Mondor de Recherche Biomédicale. "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 David H. Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "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." Xpert HCV Viral Load begins shipping this month as a CE-IVD Mark product. For more information on Cepheid's GeneXpert Systems or the complete menu of CE-IVD Xpert tests, visit www.cepheidinternational.com.