Genedrive HCV ID Kit received CE-IVD Certification

Hepatitis C assay provides decentralized molecular testing to support the identification of patients that could benefit from direct acting antiviral therapy

Genedrive plc (LSE:GDR), the molecular diagnostics company, today declares that the Company has achieved CE certification under the EU Medical Devices Directive for its Genedrive HCV ID Kit, a qualitative molecular assay for Hepatitis C (HCV). CE marking permits for introduction of the assay into Europe as well as low and middle income countries that accept CE certification under their national regulations. In other countries, CE marking can be a essential prerequisite to begin local registration procedures and is an important endorsement for potential distribution partners.

David Budd, CEO of genedrive plc, said: "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. 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 permitting for actual linkage to care, and reducing patient loss during the follow up."

The Genedrive HCV assay is performed on the Genedrive instrument, an inventive and affordable system providing molecular diagnostics at the point of essential. The proprietary assay is performed directly from a small, 25ul plasma sample and does not need a separate viral nucleic acid extraction procedure. The assay provides results within 90 minutes from lyophilised PCR reagents packaged into a single-use, disposable cartridge. Performance estimation studies to support CE marking of the assay (Institut Pasteur, Paris & Queens Medical Centre, Nottingham) demonstrated sensitivity and specificity fulfilling the requirements published by FIND, the Foundation for Innovation in New Diagnostics.