Novacyt PLC's rapid antigen test for Covid-19 has received a CE mark for the European Union, though it is still waiting for approval in the UK.
David Allmond, the diagnostics group’s chief executive, said it was one of the first approvals in the EU for a saliva-based lateral flow self-test for Covid.
Characteristics are "easy sample collection and accurate results in as little as 15 minutes”, he added. Most lateral flow tests currently require nose and throat swabs.
Novacyt said the UK had approved another of its PCR tests, called Promate COVID-19 1 Gene and used on its q16 instrument, making its third direct-to-PCR test to be approved in the UK and fourth here overall.
The company said it still had five other products awaiting evaluation by the UK Health Security Agency's Medical Devices (Coronavirus Test Device Approvals) or CTDA, including the saliva-based lateral flow test.
“Following UK validation under CTDA legislation of a number of key products in our COVID-19 portfolio over the last six months, we are well placed to continue servicing our customers' COVID-19 testing needs in the UK,” said Allmond.
“Looking ahead and more broadly, we are applying the learnings gained during the pandemic, as well as our proven track record and innovative technology to create diagnostics for new disease targets.”
Shares rose 8% to 164p.