TGA APPROVAL BOOSTS COVID TEST MAKER
GENETIC Signatures shares surged more than 5 per cent after the molecular diagnostic firm gained Australian regulatory registration for use of its Covid-19 testing technology on saliva samples.
The company has been selling its EasyScreen SARS-CoV-2 Detection Kits to hospitals and pathology laboratories around the world since the start of the pandemic almost two years ago. Up until now, the Australian-developed kits have used nasal swabs to diagnose Covid-19 but now regulators have accepted the use of saliva samples.
News that Australia’s Therapeutic Goods Administration had given the green light lit a fuse under Genetic Signatures shares, which rallied 9c or 5.4 per cent to $1.76 on Monday.
The stock has skyrocketed almost 80 per cent since this time two years ago and is up 31 per cent since the biotech’s last market update just before Christmas.
The firm flagged that after a strong year it expected sales of at least $21m for the December half.
That would be up from almost $19m in the previous first half.
“First-quarter sales were a company record $12.4m, supported by a surge in SARS-CoV-2 testing in Australia,” the company said late last month, noting that testing volumes had increased dramatically with the recent emergence of the Omicron variant of Covid-19.
Genetic Signatures CEO John Melki on Monday said he was pleased with the speed of the TGA approval and the results of a recent South African study, which found that saliva swabs could be more effective than nasal swabs for the Omicron variant in PCRbased tests.
“We’re thrilled to be part of the solution,” Dr Melki said of the company’s growth.
“We’re helping to bring this pandemic under control. That’s what motivates everybody in the company.”