Atomo's COVID-19 nasal swab test gets green light from TGA

Atomo's COVID-19 nasal swab test gets green light from TGA

Sydney-based Atomo Diagnostics (ASX: AT1) has yet another feather in its cap after authorities approved its nasal swab antigen test for COVID-19 to be used by medical professionals.

Unlike most nasal swabs on the market that need to be sent to the lab for processing, the Atomo COVID-19 antigen test can be processed at the point of care with results available after 10 minutes.

In contrast to the company's AtomoRapid COVID-19 (IgG/IgM) blood test that was given the green light in August, which is most accurate 15 days from exposure to the virus, the company believes antigen testing may have benefits for early detection.

As such, the group will be recommending health departments, labs, health professionals and aged care facility workers use both tests in tandem to account for different infection timeframes amongst patients.

The Therapeutic Goods Administration (TGA) will require all approved distributors to provide it with additional evidence to demonstrate ongoing safety and performance within 12 months of approval of the antigen test.

The Peter Doherty Institute for Infection and Immunity (Doherty Institute) has been engaged the Department of Health to assist with the post-market validation of new COVID-19 rapid tests to inform their best use.

"Atomo can now offer, in a single 15 minute window, rapid testing for both COVID-19 antigen and antibody responses," says Atomo Diagnostics co-founder and managing director John Kelly (pictured).

"This comprehensive rapid screen will help determine acute active infection and also indicate those patients who may have had prior exposure to the virus and built up an antibody response."

Kelly emphasises up to 20 per cent of infections are asymptomatic, which has led to many countries now establishing regular, proactive testing regimes. 

"Antigen tests have been proven to provide good detection of COVID-19 infection in the early stages of exposure," he says.

"We believe this makes them useful both for people showing onset of symptoms or for broad scale screening of at-risk communities and frontline workers.

"Furthermore, Atomo believes that when combined with our rapid antibody test that detects virus exposure over a longer period, they should offer excellent performance where reliable testing is most convenient and needed - outside of the laboratory."

To ensure the professional delivery of rapid testing services to organisations where there is a need, Atomo has engaged Health Solutions Group Australia, a leading provider of professional healthcare workers in Australia, to provide the professional testing services to Atomo customers.

Health Solutions' professional team of registered nurses and specialist healthcare professionals visit workplaces via customised pop-up style clinics, providing a range of point of care services, making it an ideal partner to support the launch and delivery of Atomo's rapid antigen and antibody tests to corporate and age care clients.

"We are delighted to be partnering with Health Solutions for the provision of COVID-19 screening services to our clients. Having a large national service provider with experience in professional testing to help rollout this service is very important," adds Kelly.

Australia currently has the 29th highest testing rates per capita in the world at 335,729 per million, or 8.6 million in total which puts our country in 14th position overall despite the relatively lower case count.

AT1 shares rose 12.9 per cent today to $0.35 each, but this is still well below their high of $0.63 since listing in late February.

Updated at 4:18pm AEDT on 27 October 2020.

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