genedrive plc, the near patient molecular diagnostics company, has successfully completed clinical validation studies to support a submission for CE regulatory approval of its Genedrive HCV ID Kit.

The studies, performed at Institut Pasteur, Paris, and Queen's Medical Centre, Nottingham, demonstrated an overall sensitivity of greater than 99% and specificity of 100% over a 955 sample cohort, comparing the test to the Abbott Molecular RealTime HCV Viral Load Assay. The Genedrive HCV ID Kit sensitivity, specificity, and limit of detection meet the Target Product Profile specifications for decentralised use in resource limited settings, as outlined by the Foundation for Innovation in Diagnostics (FIND). The validation studies were supported by the European Commission FP7 PoC-HCV programme.

The HCV test is performed on the company's Genedrive portable molecular diagnostics platform, designed for use at the point of need. The assay uses only a small amount of human plasma (25ul), eliminating the need for a separate RNA viral extraction process, and yields results within 90 minutes.

"Recently approved direct acting antiviral therapies have revolutionised therapeutic options for treating HCV patients, however the challenge remains to identify infected persons, many of whom are living in geographic regions that lack access to state-of-the-art diagnostics," said Dr Darragh Duffy of the Institut Pasteur. "The Genedrive HCV ID Kit is a rapid and simple to use point of need test that would enable real-time treatment and management of chronic HCV patients in decentralised settings."

"We are very pleased with the performance of the assay's sensitivity, specificity and speed. This presents the Genedrive HCV test with the opportunity to be the first to market as a decentralised, qualitative, molecular HCV test," said David Budd, chief executive officer of genedrive plc. "WHO HCV testing guidelines recommend the initiation of treatment with direct acting antiviral agents, following a qualitative or quantitative HCV molecular test. The Genedrive HCV ID Kit is well placed to support the  goal of increasing access to HCV diagnostics in decentralised laboratories in resource limited settings."

The company anticipates submission for CE certification under the EU Medical Devices Directive for Genedrive HCV ID Kit by the end of March 2017. CE certification is a key step toward product commercialisation later this year.