Genedrive PLC (LON:GDR), the molecular diagnostics company, said its Genedrive HCV ID kit has achieved CE certification under the EU Medical Devices Directive.
The Genedrive HCV ID kit is a qualitative molecular assay, or test, for Hepatitis C (HCV).
The award of the CE mark means the kit can now be marketed in Europe as well as those countries that accept CE certification under their national regulations.
READ: Genedrive secures CE mark for breakthrough diagnostic Hepatitis-C test
In other countries, CE marking can be a necessary prerequisite to begin local registration processes and is an important endorsement for potential distribution partners, Genedrive said.
"It is an exciting achievement to be the first company to launch a molecular HCV test designed to be used in smaller hospital laboratories and clinics,” said David Budd, chief executive of Genedrive.
“CE Marking will allow us to engage with many of the countries where HCV is an endemic healthcare issue. The combination of national screening programmes, the availability of cost effective treatment, and consequently a growing demand for molecular diagnostics is an area we can contribute to in a meaningful way,” he added.
“Treatment with pan-genotypic direct acting antivirals can be initiated immediately following a positive HCV result using the Genedrive HCV assay allowing for effective linkage to care, and reducing patient loss during the follow up," Budd explained.
Shares in the medtech were up 1.4% at 35p after the news.