Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for Xpert® HCV, the only molecular test in the US to detect hepatitis C virus RNA directly from a human capillary whole blood (fingerstick) sample. The Xpert HCV test is performed on the GeneXpert Xpress System.

Researchers in Spain have evaluated a minimally invasive test based on dried blood spot samples for hepatitis C RNA detection and genotyping.

Roche announced on Monday that its Elecsys HCV Duo test for hepatitis C virus (HCV) received CE marking, and it is launching in countries accepting the regulatory approval.

New guidelines from WHO strongly recommend offering self-testing for hepatitis C virus (HCV) as an additional approach to HCV testing services. WHO releases the new guidelines – its first on HCV self-testing – during the International AIDS Society Conference 2021. 

NEW YORK (GenomeWeb) Cepheid announced today it has received CE-IVD marking on a fingerstick test that can be used to quantify viral loads of hepatitis C virus. The test is now available in the EU and countries recognizing the CE mark. The t