TGA approval for Atomo Diagnostics' rapid HIV test

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Atomo Diagnostics (ASX:AT1) has announced that the TGA has approved its 'AtomoRapid HIV 1&2' rapid diagnostic test for use by medical professionals in point of care settings in Australia.

The product joins other Atomo products on the Australian Register of Therapeutic Goods, including the AtomoRapid COVID-19 Antibody Test, the Atomo COVID-19 Antigen Test, and the Atomo HIV Self Test - the first and only HIV self-test to have been approved for sale in Australia.

While there is no cure for HIV infection, early diagnosis is considered essential to ensure timely access to antiretroviral therapy.

The company said the AtomoRapid HIV (1&2) test detects the presence of HIV antibodies in a single drop of blood obtained from a fingertip. Unlike laboratory-based tests, where the patient may have to wait several days for their result to be returned, AtomoRapid HIV (1&2) gives an accurate test result in just 15 minutes.

Atomo’s managing director, John Kelly, said, “We are very pleased to have received TGA approval for our AtomoRapid HIV (1&2) professional use diagnostic test. We already manufacture and supply the only HIV self-test to have been approved for sale in Australia, so we see this latest approval as further confirmation of our expertise in this field. This latest good news follows our recent TGA approvals for rapid antigen and antibody tests that detect SARS-COV-2, the virus that causes COVID-19, and means we can now further expand our portfolio of best-in-class rapid diagnostic tests in our home market.”