Australians will soon have access to a rapid COVID-19 test where results can be obtained in just 15 minutes from a drop of blood following approval from the Therapeutic Goods Association (TGA) for Atomo Diagnostics’ (ASX: AT1) rapid antibody test.

The test device has been independently tested at laboratories in France where the AtomoRapid test has already been approved by European regulators and is sold by joint manufacturer NG Biotech.

Now with TGA approval for distribution in Australia, Atomo has a significant commercial opportunity to contribute to the containment of COVID-19 and will shortly commence supplying AtomoRapid to laboratories, medical practitioners, and healthcare professionals in aged care facilities with their first 100,000 units already allocated.

“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,” said Atomo 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.”

“We see strong potential for use of our test across a number of channels in Australia and we believe TGA approval will accelerate these negotiations. 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.”

At present, there is at least a 12 hour turnaround time for COVID-19 testing in Australia where residents can either attend dedicated testing sites which have been set up in central locations, or at a medical facility.

Using an AtomoRapid test, the one-use device analyses the drop of blood for the presence of antibodies which are created by the body in response to the COVID-19 virus. If the test identifies a targeted antibody, then the individual is likely to either have the virus or have had it in the past.

Now approved for distribution, the Peter Doherty Institute for Infection and Immunity has been engaged by the Department of Health to assist with the most effective use and allocation of rapid tests.

While the initial Australian supply of 100,000 AtomoRapid tests has been allotted, Atomo Diagnostics is in discussions with other commercial partners to potentially distribute to public health providers, corporate OH&S, aged care and other institutions. Initial markets being targetted by the Company are Australia, New Zealand, the Philippines, Hong Kong and Taiwan.

Successfully listing on the ASX in April 2020 via a $30 million IPO, Atomo has leveraged existing technology from its rapid HIV self-test to deliver this user-friendly COVID-19 test.

AT1 shares responded well to TGA approval to reach a high of $0.40, a rise of 17.6% on their previous day’s close of $0.34, and double their April IPO Issue Price of $0.20 per share.