The receipt of CE IVD certification under the EU Medical Devices Directive would green-light the commercialisation of the product in the European Union.
Genedrive’s HCV assay provides on-the-spot results in just 90 minutes direct from a very small plasma sample.
Revenues in the half year to December rose to £2.9mln (£2mln), with sales related to Genedrive up 71% to £1.2mln.
Investment in the hand-held device, however, meant losses of £2.7mln in the year. The company had cash at the period-end of £5.7mln.
David Budd, Genedrive’s chief executive, said: "The recent period has seen genedrive plc continue to focus on the significant opportunity we see in molecular diagnostics with our rapid, point of need Genedrive system.
“In Hepatitis C, we are making very positive progress. Our recent application for CE certification positions us well to be first to market with a decentralised point of need HCV qualitative test which would enable real-time treatment and management of chronic HCV patients with the new generation of direct acting antivirals.
"Despite the difficulties in accessing the full potential of the Genedrive system thus far through the MTB/RIF launch, the Board remains confident of the business strategy. “