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Atomo Diagnostics (ASX:AT1) - Managing Director, John Kelly
Managing Director, John Kelly
Source: Atomo Diagnostics
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  • Atomo Diagnostics (AT1) receives approval to supply its HIV Self-Test to a wider range of organisations
  • The Therapeutic Goods Administration (TGA) has made the changes to the product’s conditions of entry in the Australian Register of Therapeutic Goods and Services
  • The changes allow AT1 to supply the test to organisations where staff have received appropriate training and enable direct supply of the product via pharmacy websites
  • Atomo also welcomes broader updates from the TGA that allow the company to advertise its HIV Self-Test and associated website in Australia for the first time
  • Despite the news, shares have ended the day down 7.25 per cent to close at 32 cents

Atomo Diagnostics (AT1) can now supply its HIV self-test to a greater variety of organisations and begin advertising thanks to recent changes made by the Therapeutic Goods Administration (TGA).

On Tuesday, the company said the TGA had revised the conditions of entry for its Atomo HIV Self-Test in the Australian Register of Therapeutic Goods and Services.

More specifically, the TGA has broadened the organisations to which the company can supply its test, which is reportedly the only HIV self-test available in Australia.

It means Atomo can supply the product to any business, organisation or institution that employs or engages individuals who have received appropriate training.

The varied conditions, which are inclusive of pharmacies, also allow Atomo to supply the test directly via pharmacy websites.

In addition to the changes, AT1 said it welcomed recent updates to advertising requirements regarding HIV tests earlier this month.

The broad changes made by the TGA permit advertisements about HIV tests in any form or media and thereby enable Atomo to market its product in Australia.

It’s a positive step for the company which, prior to the update, was unable to advertise or promote its HIV Self-Test or its associated website.

Atomo’s co-founder and managing director John Kelly commented on the news.

“We are delighted that Atomo and its partners can now actively promote HIV self-testing, expand much needed awareness as to the availability of our TGA-approved rapid HIV Self-Test and work with pharmacy groups to ensure that the HIV Self-Test is widely available in stores and online,” he said.

“As leaders in the design of easy-to-use rapid diagnostic test platforms, we are pleased to see the long-term resistance to rapid and home-based testing here in Australia across infectious disease applications such as HIV and COVID-19 softening and welcoming the arrival of rapid testing to the Australian market.”

The company thanked the Australian Federation of Aids Organisation and The Pharmacy Guild of Australia for their collaboration with Atomo and the TGA.

Despite the news, company shares were down 7.25 per cent to trade at 32 cents at market close.

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