MEDIA RELEASE: First HIV self-test approved for sale in Australia now available from Atomo Diagnostics

SYDNEY, Australia,4 April 2019 | Award-winning medical device developer Atomo Diagnostics today announced that its Atomo HIV Self Test – the first and only diagnostic self-test for HIV that has been formally reviewed and approved by the Therapeutic Goods Administration (TGA) – is now available to the Australian public.  The test can be bought directly from Atomo via its dedicated website:  The product is also available from selected clinics in Australia.

The Atomo HIV Self Test enables the user to test their blood for the HIV antibodies produced in response to HIV infection.  The handheld device needs only a small drop of blood from the fingertip, and gives an accurate result in just 15 minutes.  Its unique, integrated design comprises an inbuilt sterile safety lancet, patented blood collection and delivery mechanism, and a highly sensitive HIV diagnostic test strip.  The product pack includes vital link-to-care information to enable the user to obtain further guidance, counselling, and follow-on referrals.

Addressing the media, Founder and CEO of Atomo Diagnostics, John Kelly, explained:  

“From today, people in Australia will be able to go online, or visit a clinic, and order an Atomo HIV Self Test that can be delivered in plain wrapping to their home or workplace so that they can test themselves in private.  After use, the product can be disposed of safely in the discreet bag included with each test.  As the first HIV self-test to be approved for sale in Australia, this is an important moment in Australia’s fight against HIV/AIDs.”

HIV self‑testing is the process whereby a person who wants to know their HIV status collects their own specimen, performs their own test in private, and interprets their own test result.  Such tests are a means to increase testing frequency in populations with a higher prevalence of HIV; and also to reach people who, perhaps due to embarrassment or fear of stigmatisation, are not currently presenting at healthcare facilities for testing.  Largely due to the convenience and confidentiality it affords, HIV self-testing is considered an essential tool to facilitate earlier and more extensive diagnosis and treatment.

John Kelly continues: 

We designed the Atomo HIV Self Test specifically to meet the needs of self-testers. It is the only product approved by the TGA for HIV self testing, a fact of which we are particularly proud, meaning that people can be confident of its safety and accuracy.  And the launch today of our new online sales channel – – means that this approved self-test is now available to anyone in Australia who wants to check their HIV status in the privacy and comfort of their own home.” 

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Atomo Diagnostics is a specialist medical device company, based in Sydney, Australia.  The company designs, develops, and commercialises innovative blood-based rapid diagnostic test (RDT) solutions for self-testing and professional use, including the Atomo HIV Self Test. 

Atomo’s refreshing, user-centred approach to design and willingness to reimagine what has gone before has led it to create products that are simpler to use and that help prevent common user errors associated with standard RDT kits.  The recipient of multiple international awards for design and innovation, Atomo’s all-in-one platform devices put the end user first and make it easy to test and screen for a range of infectious diseases and chronic conditions.

As well as commercialising products in its own name, Atomo provides OEM product development services to specialist diagnostic and pharmaceutical companies worldwide.

For more information, please contact:

John Kelly (CEO)                                                        ​

Atomo Diagnostics                                                  ​

Tel: +61 (2) 9099 4750