- COVID-19 test supplier, Genetic Signatures (GSS) has submitted applications to sell its rapid coronavirus detection kits in Australia and Europe
- Using its technology, Genetica can test up to 188 patient samples in just 4.5 hours
- The company is prepared for the anticipated high orders it will receive for the kits
- Genetic is up 34.6 per cent on the market today, trading for $1.48
COVID-19 test supplier, Genetic Signatures (GSS) has submitted applications to sell its rapid coronavirus detection kits in Australia and Europe.
Since the beginning of the year, when it became apparent that COVID-19 outbreak was a serious global problem, Genetic has developed a SARS-CoV-2 specific test, using its 3base technology.
Data has been generated to support the submissions as required by the European IVDD (in vitro diagnostic directive) and TGA Medical Device Regulation (ARGMD) to allow the product to be marked as an in vitro diagnostic (IVD) device in Australia and Europe.
The product can test up to 188 patient samples in approximately 4.5 hours with minimal hands-on time for laboratory technicians.
As a global supplier of COVID-19 test kits, Genetic expects it will be classified as an essential service and will not see operations impacted by the increasingly strict lockdowns.
The company has introduced laboratories in Europe and Australia to both the new test and its 3base technology and has manufacturing facilities in Sydney, to meet the anticipated high-volume orders.
Genetic Signatures CEO, Dr John Melki, says Genetic has recently increased its capabilities in Europe and are ready to serve hospitals and test labs across the U.K. 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 EasyScreenTM Respiratory Pathogen Detection Kit which identifies more than 14 common respiratory pathogens,” he said.
“Our hope is it will help clinicians move faster and better manage their urgent work, to detection infection and save lives,” he added.
Genetic is up 34.6 per cent on the market today, trading for $1.48 at 12:50 pm AEDT.