Genedrive plc, the near patient molecular diagnostics company, has announced submission of its Genedrive HCV ID Kit for CE IVD certification under the EU Medical Devices Directive. Receipt of CE IVD certificaton will allow commercialisation of the product within the EU and in resource limited countries in the rest of the world that accept CE certification under their national regulations. Where local registration is required, CE marking is often a prerequisite.
The application for CE Marking is supported by excellent performance data in recent clinical validation studies. These studies, performed at Institut Pasteur, Paris, and Queen's Medical Centre, Nottingham, show that the Genedrive HCV ID Kit sensitivity, specificity, and limit of detection meet the Target Product Profile specifications for decentralised use in resource limited setting as outlined by the Foundation for Innovation in Diagnostics (FIND).
The qualitative molecular HCV assay allows for decentralised testing of Hepatitis C (HCV), providing results within 90 minutes direct from a small plasma sample (25ul). The Genedrive HCV assay demonstrated a sensitivity of greater than 99% and specificity of 100% over the 955 sample cohort when comparing the assay to the Abbott Molecular RealTime HCV Viral Load test. The assay is performed on the Genedrive platform, a portable molecular diagnostics system designed for use at the point of need.
Professor William Irving, Professor of Virology at Queens Medical Centre Nottingham, and clinical virology expert in hepatitis diagnosis, management and pathogensis, was the lead investigator at the UK site involved with the clinical performance assessment of the Genedrive HCV assay.
Professor Irving said, "The diagnostic and treatment landscape for HCV has changed rapidly in recent years, and with the introduction of direct acting antivirals, there is a real opportunity to tackle the global burden of Hepatitis C. Accurate, decentralised diagnostics, like Genedrive HCV, promise to be a big step forward in addressing the challenges associated with identifying and diagnosing those living with HCV infection and to give them access to this new and effective therapy."
David Budd, chief executive officer of genedrive plc said, "Application for CE Marking for the Genedrive HCV assay is a significant step in our development of a decentralised and qualitative molecular HCV test, which could be the first of its kind to market. As we go through this process, we look forward to updating the market with our commercial partnership arrangements and target geographies for initial product introductions."