SYDNEY: Atomo Diagnostics Limited announced that the Therapeutic Goods Administration (TGA) has approved its rapid SARS-CoV-2 antibody blood test for use by medical professionals in Australia.
With approval now granted for the Atomo Rapid COVID-19 (IgG/IgM) test, the product will now be added to Atomo’s existing Australian Register of Therapeutic Goods (ARTG) listing, alongside the Atomo HIV Self-Test. This is a routine procedure which is expected to be completed shortly.
Once listed, Atomo can commence supply of the test to departments of health, laboratories, medical practitioners and health care professionals in aged care facilities in Australia. The Atomo Rapid COVID-19 (IgG/IgM) testis jointly manufactured by Atomo and NG Biotech in France, with NG Biotech manufacturing the test strip and Atomo manufacturing the device and being the listed manufacturer.
The Atomo test approved by the TGA is the same as the test that is already approved and being sold by NG Biotech in France. Atomo Diagnostics co-founder and Managing Director John Kelly said, “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.”
Mr Kelly added, “Atomo already sells Australia’s only approved HIV Self-Test and we know that our solutions implifies rapid blood-based 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.”
Atomo has had preliminary commercial discussions to assess distribution channels for its test within Australia. Now that TGA approval has been received, Atomo will further engage across segments where itbelievesCOVID-19 antibody testing has a significant role to play.
John Kelly commented, “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.”