Rapid HCV test gets European approval

Cepheid announced that its quantitative hepatitis C virus infection viral load test, Xpert HCV Viral Load, has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices, according to a press release.

The test was approved as a medical device and will enable HCV viral load to be detected and monitored, while producing results in less than 2 hours. The test is intended for use as an aid in managing HCV-positive patients undergoing antiviral therapy and can be used to measure HCV RNA levels at baseline and during treatment, help predict sustained and nonsustained virological responses to HCV therapy and be used to confirm HCV serologic test results, according to the release.

“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,” Jean-Michel Pawlotsky MD, PhD, professor of medicine at the University of Paris-Est and director of the National Reference Center for Viral Hepatitis B, C and Delta, said in the release. “It is a very sensitive test for confirmation of infection and monitoring of HCV, and will assist in better patient management.”

“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,” John Bishop, chairman and chief executive officer of Cepheid, said in the release. “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.”

The release stated that Xpert HCV Viral Load will be shipped as a CE-IVD Mark product this month.

Disclosure: Bishop is an employee of Cepheid. Pawlotsky’s financial relationships were not known at the time of publication.