US-based molecular diagnostics firm Cepheid has received European approval for its quantitative test, Xpert HCV Viral Load.
The company has secured CE-IVD status for the test, which offers on-demand molecular testing for confirmation of infection and monitoring of Hepatitis C virus (HCV).
Cepheid chairman and CEO John Bishop said: "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.
"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 test will be carried on the Cepheid GeneXpert System, a molecular diagnostic platform with around 8,000 systems deployed across the globe.
According to the company, the Xpert HCV Viral Load has been developed for use as an aid in the management of HCV infected patients undergoing antiviral therapy.
It will be used to measure HCV RNA levels at baseline and during treatment, in addition to predicting sustained and nonsustained virological responses to HCV therapy. It can also be used for confirmation of HCV serologic test results.