Genedrive shares jump as Covid-19 test maker files for UK approval
Covid-19 test maker Genedrive has filed for approval to sell its product in the UK, after new testing regulations came into effect last month.
Shares jumped 14.4 per cent to 41.5p per share by mid-morning.
The new Coronavirus Test Device Approvals (CTDA) regulations place specific performance requirements on test suppliers, after the new pandemic-era industry was accused of being the ‘wild west’ of diagnostics.
The molecular diagnostics company’s COV19-ID Kit has been found to have a 98 per cent specificity and a 98 per cent sensitivity.
The Kit’s can notify users of a positive result in 7.5 minutes, Genedrive added, while negative results can take around 17 minutes.
The efficacy of the tests already meets the Medicines and Healthcare Regulatory Agency (MHRA) current requirements, Genedrive said in a regulatory filing today.
“The next milestone is approval by the Department of Health and Social Care,” said Genedrive CEO David Budd. “However, no assured timeline is provided on how long the review under CTDA regulations will take, given a current backlog in their reviews.”
“We have confidence in our data and the application is another positive step that allows us now to progress UK focused commercial discussions.”