- Atomo Diagnostics (AT1) has received the tick of approval from the Australian Therapeutic Goods Administration for its COVID-19 rapid antibody blood test, AtomoRapid
- The approval means Atomo can sell its COVID-19 tests to medical professionals
- The product will now be added to Atomo's Australian Register of Therapeutic Goods listing, along with the HIV Self-Test
- AtomoRapid is jointly manufactured with French company NG Biotech, who is already selling the tests in France
- Now that the TGA has approved the tests, the company will now engage across segments where it believes COVID-19 antibody testing will play a significant role
- Atomo is up 8.82 per cent on the market this morning and is trading for 37 cents per share
Atomo Diagnostics (AT1) has received the tick of approval from the Australian Therapeutic Goods Administration (TGA) for its COVID-19 rapid antibody test.
The approval means that medical professionals in Australia can now use the company's COVID-19 blood test, AtomoRapid. The product will now be added to Atomo's Australian Register of Therapeutic Goods (ARTG) listing, with the HIV Self-Test.
Once it is listed on the ARTG, Atomo can start supplying the test to departments of health, laboratories, medical practitioners and health care professionals in aged care facilities in Australia.
AtomoRapid is jointly manufactured by Atomo and a French company, NG Biotech. NG manufactures the test strip, while Atomo manufactures the device. The test has already been approved and sold by NG in France.
Atomo co-founder and Managing Director, John Kelly, is pleased with the approval.
"Atomo already sells Australia’s only approved HIV Self-Test and we know that our solution simplifies rapid blood-based testing in point-of-care settings," he said.
"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," he added.
Atomo has had commercial discussions to assess distribution channels for its test within Australia. Now that the TGA has approved the tests, the company will now engage across segments where it believes COVID-19 antibody testing will play a significant role.
“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," John explained.
"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 added.
Atomo is up 8.82 per cent on the market this morning and is trading for 37 cents per share at 11:25 am AEST.