Genedrive PLC (LON:GDR) is nearing a landmark for its breakthrough rapid diagnostic for Hepatitis-C with the AIM-listed group ready to submit its breakthrough for regulatory approval.
The receipt of CE IVD certification under the EU Medical Devices Directive would green-light the commercialisation of the product in the European Union.
The application for CE Marking will be supported by the recent “excellent” performance data from a clinical validation study carried out at Institut Pasteur, Paris, and Queen's Medical Centre, Nottingham.
Genedrive’s HCV assay provides on-the-spot results in just 90 minutes direct from a very small plasma sample.
The trials revealed the technology was highly accurate and performed well against the best-in-class device.
“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,” said David Budd, Genedrive chief executive.
“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."