Covid-19 test maker Genedrive has applied for permission to sell its product in the UK, after new testing regulations came into force last month.
Shares jumped 14.4% to 41.5p per share by mid-morning.
New Coronavirus Test Device Approvals (CTDA) regulations place specific performance requirements on test providers, after the new pandemic-era industry has been accused of being the ‘wild west’ of diagnostics.
The Molecular Diagnostics Company’s COV19-ID kit was found to have a specificity of 98% and a sensitivity of 98%.
The kit can notify users of a positive result in 7.5 minutes, Genedrive added, while negative results can take around 17 minutes.
The effectiveness of the tests already meets the current requirements of the Medicines and Healthcare Regulatory Agency (MHRA), Genedrive said today in a regulatory filing.
“The next step is the approval by the Department of Health and Welfare,” said Genedrive CEO David Budd. “However, no assured schedule is provided on the duration of the exam under CTDA regulations, given the current backlog of their exams.”
“We are confident in our data and the app is another positive step that now allows us to take the UK-focused trade discussions forward. “