Genedrive gets clearance for Hepatitis C assay

Manchester-based molecular diagnostics company Genedrive has received CE certification for its qualitative molecular testing for Hepatitis C – branded Genedrive HCV ID Kit.

CE marking allows the introduction of the assay into Europe as well as low and middle-income countries which accept CE certification under their national regulations.

Genedrive chief executive David Budd said: “It is an exciting achievement to be the first company to launch a molecular HCV (Hepatitis C0 test designed to be used in smaller hospital laboratories and clinics.

“CE Marking will allow us to engage with many of the countries where HCV is an endemic healthcare issue.

“The combination of national screening programs, the availability of cost effective treatment, and consequently a growing demand for molecular diagnostics is an area we can contribute to in a meaningful way.

“Treatment with pan-genotypic direct acting antivirals can be initiated immediately following a positive HCV result using the Genedrive HCV assay allowing for effective linkage to care, and reducing patient loss during the follow up.”