PRESS RELEASE: Australian TGA approves Atomo HIV Self Test as first rapid diagnostic test for home use

SYDNEY, Australia,29 November 2018: Award-winning medical device developer Atomo Diagnostics today announced that its Atomo HIV Self Test has been approved for sale in Australia by the Therapeutic Goods Administration (TGA).  It is the first and only diagnostic self-test for HIV to have received approval from Australia’s national regulator.


HIV self‑testing is the process whereby a person who wants to know his or her HIV status collects their own specimen, performs their own test in private, and interprets their test result.  Earlier this year, the Australian Federation of AIDS Organisations (AFAO) issued its HIV Self-Testing – Update and noted that “it would welcome the approval in Australia of HIV self-tests.” Such tests are a means to increase testing frequency in populations with a higher prevalence of HIV and to reach people 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 diagnosis of HIV; this is critical if Australia is to reach its target of virtual elimination of HIV transmission in Australia.

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

“The TGA is hugely respected around the world for it’s stringent quality standards. To have secured its approval for a HIV self-test product is a major achievement for Atomo, and is something of which we are very proud. We are an Australian company and knowing that the product we have developed can now also benefit Australians is especially gratifying.”

Designed for lay users, the integrated Atomo HIV Self Test is a simple handheld device that incorporates a sterile safety lancet, unique patented blood collection and delivery system, and a highly sensitive HIV diagnostic test strip. Quick and easy to use, the test needs only a small drop of blood from the fingertip.  The test detects HIV antibodies produced in response to infection, and the test result is displayed within 15 minutes.  The product pack includes vital link-to-care information to enable the user to seek guidance, counselling and follow-on referrals.


In independent studies involving untrained self-test users, carried out in Europe, Africa, and Australia, the Atomo HIV Self Test demonstrated excellent performance and concordance to laboratory results, making it a reliable and effective screening tool for HIV in the home.  Also approved for sale in Europe, where the product is CE marked, the test has likewise been evaluated and passedby the WHO Expert Review Panel for Diagnostics (ERP-D) for procurement by the Global Fund and Unitaid.

Another important milestone having been reached, John Kelly explains what’s next for Atomo:

“Beyond our commitment to increasing global access to effective HIV testing, we also develop rapid diagnostic test devices for medical and pharmaceutical companies worldwide. In collaboration with respected international partners, we are working on multiple projects that incorporate our patented device technologies.  A number of additional test applications for professional use and self-testing are forthcoming, including tests for Hepatitis C virus.”

In the wake of this landmark TGA approval, the Atomo HIV Self Testwill be made widely available throughout Australia in the coming months.

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Atomo Diagnostics is a specialist medical device company, based in Sydney, Australia.  The company designs, manufactures, 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)                                                        Tim Allerton or Andrew Geddes

Atomo Diagnostics                                                      CityPR

Tel: +61 (2) 9099 4750                                               Tel: +61 (2) 9267 4511