TGA greenlights use of saliva samples in Genetic Signatures’ Covid-19 testing technology

Genetic Signatures shares got a boost after Australia’s health regulator allowed the use of saliva samples in the diagnostic firm’s Covid-19 testing technology.

A health worker swabs a woman at a Covid-19 testing clinic in Brisbane. Picture: NCA NewsWire / Dan Peled

GENETIC Signatures shares surged more than five 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.

Saliva testing is already available in Europe and now Australia’s Therapeutic Goods Administration has given the green light. Genetic Signatures hopes US regulators will soon follow suit.

The TGA approval lit a fuse under Genetic Signatures shares which rallied 9c or 5.4 per cent to $1.76 on Monday..

Genetic Signatures shares have skyrocketed almost 80 per cent since this time two years ago and are up 31 per cent since the biotech’s last market update just before Christmas.

The company flagged in its December announcement that after a strong year it expected sales of at least $21m for the first half of the year. That would be up from almost $19m in the previous December half.

Genetic Signatures CEO Dr John Melki in the diagnostic company's laboratory.

“First quarter sales were a company record $12.4m supported by a surge in SARS-CoV-2 testing in Australia,” Genetic Signatures said late last month, noting that testing volumes had increased dramatically with the recent emergence of the Omicron variant of Covid-19.

“This increased testing will likely continue into 2022.”

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 in the Omicron variant in PCR based tests.

He said this was different to other variants such as Delta that are more reliably detected from a nasal swab, because they are found more in the lungs than throat.

“Our team is driven to provide our customers with the highest quality tests and are constantly looking at ways to improve our products so they remain effective in detecting pathogens,” Dr Melki said.

“With Omicron becoming the dominant strain of the SARS-CoV-2 virus it is likely that this new methodology will be needed to identify all cases of this new variant.”

Genetic Signatures was founded in 2001 by the late Dr Geoffrey Grigg, a former chief of the molecular biology division of the Commonwealth Scientific and Industrial Research Organisation (CSIRO).

The company listed on the ASX in 2015 and posted a net profit of $1.76m last financial year from revenue of $28.3m as demand for Covid-19 testing increased and it began exporting to Europe and the United States.

Last financial year, 21 per cent of the company’s revenue came from exports due to the explosion in Covid-19 cases globally.

“We’re thrilled to be part of the solution,” he says of the company’s growth. “We’re helping to bring this pandemic under control. That’s what motivates everybody in the company.”

Dr Melki said Genetic Signatures was currently working on a major update to technology which it expects will hit the market in the next 18 months to two years.

“We are already developing the next generation of (testing) instrument. The user will just have to put a sample into the instrument and it will do the rest. It will process the sample, run the test and report the result back to the hospital or laboratory’s computer system.

“We are very excited by it and we really think this type of instrument will be a game changer.”

He said the technology would test for multiple targets in highly automated fashion.

“Especially considering that when this pandemic calms down you are still going to have people with symptoms of a sore throat or running nose ... it could be influenza or a mild coronavirus.

“Our technology is designed to give the doctors that information as to what is actually infecting the patient.”