Australian firm Genetic Signatures has filed to register both at home and abroad a new coronavirus detection kit capable of testing nearly 200 patient samples in under five hours.
The specialist molecular diagnostics company’s detection kits can, when used with supplied instruments, test a batch of 188 patient samples in roughly 4.5 hours with “minimal” hands-on time for lab technicians.
And while the first shipment has already made it to Europe under short-term regulatory exemptions, the Sydney-based company has now formally applied for European CE-IVD registration that would guarantee long-term supply throughout Europe and the United Kingdom.
Chief executive John Melki said the company was ready to serve hospitals and test labs across the UK and European Union.
He said customers would be able to use the test to screen for coronavirus on its own or as part of a pre-existing pathogen detection kit.
“Our hope is it will help clinicians move faster and better manage their urgent work, to detect infection and save lives,” Mr Melki said.
Genetic Signatures has also submitted an application for inclusion of the detection kit – known as 3base EasyScreen – on the Australian Register of Therapeutic Goods.
The company was in a temporary trading halt from March 26 to March 30 pending this announcement.
Following the announcement, Genetic Signature’s stock price has surged 27 per cent, or 29 cents, to $1.40 by 1450 AEDT.