Atomo Diagnostics (ASX: AT1) expects to soon start selling its rapid COVID-19 antibody blood test in Australia following the Therapeutic Goods Administration's (TGA) approval for its use by medical professionals.
The AtomoRapid COVID-19 (IgG/IgM) test is jointly manufactured by Atomo and its French partner NG Biotech, which makes the test strip while the Australian company produces the testing device itself.
The breakthrough means Sydney-based Atomo will soon have its second Australian Register of Therapeutic Goods (ARTG) listing, alongside the Atomo HIV Self-Test.
AT1 shares were up 13.24 per cent at $0.385 each at 2:08pm AEST.
Today's announcement is the result of an expanded partnership with NG Biotech giving Atomo an exclusive market in several countries.
On 4 June, the company secured the exclusive rights as the listed manufacturer to market and distribute the COVID-19 antibody test in Australia, New Zealand, Singapore, Malaysia, Indonesia, Taiwan, Hong Kong, Thailand, Vietnam, Myanmar and the Philippines.
Until that date, NG Biotech had already ordered more than 1.5 million of Atomo's Galileo devices for use in its COVID-19 antibody test in France.
Atomo's global expansion continued in late July after signing a binding agreement with US-based diagnostics specialist Access Bio Inc (KOSDAQ: 950130) to supply its devices for the North American market, with co-branding from both companies.
Under the agreement, Access Bio is obliged to sell a minimum of two million products by 30 September 2021.
Regulatory approval in Australia may represent a relatively small achievement in comparison, although testing rates per capita are relatively high here (20th in the world).
Atomo also plans to submit its product for assessment to the Doherty Institute, which has been engaged by the Department of Health to assist with the post-market validation of new COVID-19 rapid tests, upon listing on the ARTG.
"Thanks to the TGA approval and the work of our dedicated team, we can now deliver what is in our view, a high-quality, reliable antibody rapid test to Australia," says Atomo Diagnostics co-founder and managing director John Kelly.
"Atomo already sells Australia's only approved HIV Self-Test and we know that our solution simplifies rapid bloodbased testing in point-of-care settings.
"We are excited that our test can now be used in our home market, Australia, to assist in the fight against the COVID-19 pandemic."
Kelly highlights two French studies of Atomo's Galileo device for testing COVID-19 had specificity rates, meaning how well the test correctly identifies a negative result, of 100 per cent.
For sensitivity, meaning the ability of the test to correctly identify positive cases, the rates were around 97 per cent.
In a report to Federal Health Minister Greg Hunt, Australia's Chief Scientist Dr Alan Finkel referenced Atomo in his discussion of the specificity of available COVID-19 tests.
"For as long as the prevalence of COVID-19 is low in Australia and available serological tests are not approaching 100 per cent specificity, serological testing to measure the prevalence of COVID-19 will not be meaningful," Dr Finkel said in the report.
"As noted earlier, the Atomo rapid test meets this requirement having demonstrated 100% specificity in both studies in France."
Kelly concludes TGA approval will accelerate negotiations for use of the test across a number of channels in Australia.
"In our view, the performance data for the test generated from independent French studies and the proven ease-of-use of the Atomo device in the field, make our test well suited for deployment in a large country like Australia, with a variety of point of care settings," he says.
Updated at 2:18pm AEST on 10 August 2020.