Genetic Signatures applies to market coronavirus test kit throughout UK and EU
CE mark approval will allow the test kit to be sold in the UK and all European Union countries.
Molecular diagnostics company Genetic Signatures (ASX: GSS) has submitted a European CE in vitro diagnostics registration application for its new 3base EasyScreen coronavirus detection kit.
The kit complements the company’s existing EasyScreen respiratory pathogen detection kit which identifies 14 common respiratory pathogens including influenza A and B, rhinovirus and M. pneumoniae and allows a large number of samples to be simultaneously tested for a range of organisms with high accuracy.
Both kits can be used on high throughput instruments to rapidly detect up to 188 patient samples in less than five hours with minimal hands-on time for laboratory technicians.
3base is a world first, proprietary platform technology designed to simplify genetic detection of microbial organisms in urine, blood or stool tests.
European marketing
Successful CE approval will allow the EasyScreen coronavirus detection kit to be marketed in Europe and the United Kingdom.
Data submitted for European approval will also support a planned US Food and Drug Administration Emergency Use Authorisation regulatory application in the near term.
Genetic Signatures has established labs in Europe and Australia to test the new kit as well as the 3base technology.
Licenced Australian laboratories have been permitted to self-validate the tests to use the kits commercially.
The company also has manufacturing capacity at its Sydney plant to meet anticipated initial high-volume orders.
Significant opportunity
Chief executive officer Dr John Melki said CE-IVD marking and inclusion on the Australian Register of Therapeutic Goods creates a significant opportunity as laboratories and governments seek fast and accurate tests for the virus.
“We recently increased our capabilities in Europe and are ready to serve hospitals and test labs across the UK and European Union,” he said.
“Customers will be able to use the test to screen for coronavirus on its own or as part of our existing detection kit which identifies more than 14 common respiratory pathogens.”
“Our hope is it will help clinicians move faster and better manage their urgent work, to detection infection and save lives.”
As a global supplier of COVID-19 test kits, Dr Melki expects the company will be classified as an essential service and will not see its operations impacted by increasingly strict lockdowns.
At midday, shares in Genetic were trading 34.55% higher at $1.48.