Specialist molecular diagnostics company Genetic Signatures (ASX: GSS) is sending its first shipments of a new Covid-19 testing kit to labs in Europe and Australia, with its manufacturing facilities in Sydney gearing up for "anticipated initial high-volume orders".
The company announced today it had submitted formal applications to European and Australian regulators to register the kits, and its shares jumped 23.64 per cent to $1.36 each.
Since the beginning of the year when it became apparent the Covid-19 outbreak was a serious global problem, Genetic Signatures has directed resources to develop a test for the coronavirus strain that causes it - SARS-CoV-2.
By supplementing existing assays and utilising its unique 3base technology, Genetic Signatures reports it has been able to specifically identify SARS-CoV-2.
Genetic Signatures' current EasyScreen Respiratory Pathogen Detection Kit and the new SARS-CoV-2 Detection Kit can be used on high throughput instruments that allow for rapid detection of up to 188 patient samples in approximately 4.5 hours with minimal hands-on time for laboratory technicians.
Confirmation from European regulators would allow for the continued marketing and supply throughout Europe and UK, as regulatory exemptions are for a defined period.
The data submitted for European approval will also support a planned FDA EUA (Emergency Use Authorisation) regulatory application in the USA in the near term.
At home, the company has sought inclusion on the Australian Register of Therapeutic Goods (ARTG). Licensed Australian laboratories are permitted to self-validate the tests to use the kits commercially.
Genetic Signatures CEO Dr John Melki says the company recently increased its capabilities in Europe and is ready to serve hospitals and test labs across the UK and European Union.
"Customers will be able to use the test to screen for the SARS-CoV-2 on its own or as part of our existing EasyScreen Respiratory Pathogen Detection Kit which identifies more than 14 common respiratory pathogens," says Melki.
"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 Genetic Signatures expects it will be classified as an essential service and, as such will not see its operations unduly impacted by increasingly strict lockdowns.
However, the group does note worldwide supply chain constraints could impact its ability to supply product to more remote locations.
Updated at 6:20pm AEDT on 30 March 2020.
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