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, in Paris, and Queen's Medical Centre, Nottingham.
Simple and speedy
Genedrive’s HCV assay for Hep-C 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.”
Genedrive describes itself as a molecular diagnostics company.
It is developing and commercialising a low cost, rapid, versatile, simple to use and robust “point of need” system that accurately picks up infectious diseases.
The Genedrive platform and its MTB/RIF test for tuberculosis have already launched in India.
As mentioned above the HCV test has undergone rigorous and successful testing with researchers in Paris and Nottingham ahead of the start of sales in the EU.
The studies demonstrated an overall sensitivity (accurate diagnosis) of greater than 99% and specificity (people don’t have disease) of 100% over a 955 sample cohort compared to the Abbott Molecular RealTime HCV Viral Load Assay.
The test was aimed decentralised use in areas with limited or non-existent health care infrastructure.
The assay used only a small amount of human plasma, eliminating the need for a separate RNA viral extraction process, and yielded results within 90 minutes.
Professor William Irving, Professor of Virology at Queen’s Medical Centre, 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."