Genetic Signatures' Covid-19 testing kit receives regulatory approval

14 April 2020, Written by David Simmons

Genetic Signatures' Covid-19 testing kit receives regulatory approval

A new rapid testing kit that can detect the virus which causes Covid-19 has been given the tick of approval from the Therapeutic Goods Administration (TGA).

Genetic Signatures' (ASX: GSS) SARS-CoV-2 Detection Kit has been approved for inclusion in the Australian Register of Therapeutic Goods (ARTG), giving the company greater access to patients during the Covid-19 pandemic and upcoming flu season.

The kit can be used on high throughput instruments to allow for rapid detection of up to 188 patient samples in under five hours with minimal interaction required from laboratory technicians.

The TGA's approval follows formal European authorisation for the kit which was announced on 4 April.

"We thank the TGA for moving so quickly and the opportunity to support the important national and international effort to rapidly and accurately test, treat and contain the spread of coronavirus throughout the community," says Genetic Signatures CEO Dr John Melki (pictured).

Several domestic private and public testing labs are already using the EasyScreen detection kit and the new SARS-CoV-2 test can be used alongside the broader respiratory kit which detects 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," says Dr Melki.

Shares in Genetic Signatures spiked up 10.59 per cent to $1.99 on the news from the TGA this morning.

Life sciences company Cellmid Limited (ASX: CDY) has also confirmed today that the first shipment of 12,000 SARS-CoV-2 rapid diagnostic tests have arrived in Sydney.

The test, manufactured by Chinese company Wondfo Biotech, detects antibodies to SARS-CoV-2. If antibodies are discovered doctors can confirm that a patient has been exposed to Covid-19 and is likely to convey immunity to the coronavirus.

Cellmid says this test will be likely used to confirm whether someone is able to return to work or not.

Updated at 4:40PM AEST on 14 April 2020.

Author: David Simmons





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