Molecular assay for hep C achieves CE certification

Molecular diagnostics company, genedrive, has achieved CE certification for its qualitative molecular assay for hepatitis C (HCV) — Genedrive HCV ID Kit.

This CE certification, which has been granted under the EU Medical Devices Directive, allows the kit to be introduced into Europe and other countries that accept CE certification under their respective national regulations.

“It is an exciting achievement to be the first company to launch a molecular HCV 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,” specified David Budd, CEO of genedrive. “The combination of national screening programmes, 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.”

The assay is performed directly from a small, 25 µL plasma sample and does not require a separate viral nucleic acid extraction process. It is stated that it can provide results within 90 minutes from lyophilised PCR reagents packaged into a single-use, disposable cartridge.