Molecular diagnostics firm Genedrive has submitted its hepatitis C test, the Genedrive HCV ID Kit, for CE marking certification in the European Union.
The company has submitted an application for the HCV ID kit for CE IVD certification under the EU medical devices directive.
The application was submitted based on performance data in recent clinical validation studies, which were carried out at Institut Pasteur in Paris and Queen's Medical Centre in Nottingham.
Genedrive’s qualitative molecular HCV assay has been designed for decentralised testing of Hepatitis C (HCV), which will offer results within 90 minutes direct from a small plasma sample (25ul).
According to the company, the studies demonstrated that the HCV ID kit sensitivity, specificity, and limit of detection reached the target product profile specifications for decentralised use in resource limited setting as per the Foundation for Innovation in Diagnostics (FIND).
The HCV assay showed a sensitivity of more than 99% and maximum pecificity the 955 sample cohort when compared against the assay to the Abbott molecular realtime HCV viral load test, said Genedrive.
The assay will be carried out on the Genedrive platform, a portable molecular diagnostics system developed for use at the point of need.
Genedrive CEO David Budd 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."
Image: Genedrive has submitted an application for HCV ID kit for CE IVD certification. Photo: courtesy of jk1991 / FreeDigitalPhotos.net.