Genetic Signatures sends first shipments of Covid-19 testing kits

Genetic Signatures sends first shipments of Covid-19 testing kits

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.

Subscribe Now!
Four time-saving tips for automating your investment portfolio
Partner Content
In today's fast-paced investment landscape, time is a valuable commodity. Fortunately, w...
Etoro
Advertisement

Related Stories

PlaySide Studios strikes deal with Warner Bros to create Game of Thrones PC game

PlaySide Studios strikes deal with Warner Bros to create Game of Thrones PC game

Five months after announcing it signed a multi-game licence agreeme...

HMC Capital enters private credit market with $127.5m purchase of Payton Capital

HMC Capital enters private credit market with $127.5m purchase of Payton Capital

After more than a year of due diligence and amidst plans to lift it...

Cost of living elevates salaries and perks as key drivers of employee retention in 2024

Cost of living elevates salaries and perks as key drivers of employee retention in 2024

The cost of living is making salaries and perks just as important a...

Enterprise roll-out "one of the biggest launches in Canva's history" as ARR hits $2.2b

Enterprise roll-out "one of the biggest launches in Canva's history" as ARR hits $2.2b

Sydney-headquartered graphic design and visualisation tool giant Ca...