29 Nov Atomo HIV Self Test approved by TGA
Today, Atomo Diagnostics 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.
Addressing the media following the announcement, 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.”
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 Test will be made widely available throughout Australia in the coming months.