Calls for regulator to fast-track HIV self-testing kits
Australia’s peak body for HIV organisations says new technology that allows people to self-test for HIV at home should be fast-tracked by the Therapeutic Goods Administration (TGA).
The Australian Federation of AIDS Organisations (AFAO) has appealed to the TGA to expedite approval of HIV self-testing to increase earlier diagnosis of HIV in the community and early treatment for newly diagnosed PLHIV.
Despite the first home testing kit going on sale in the UK in 2015, to date the TGA has not approved HIV self-testing devices in Australia.
Australian research shows that HIV self-testing among higher risk gay men doubled testing rates, while among infrequent testers the rate of testing increased by a factor of five.
The AFAO submission to the current TGA review calls for the accelerated approval of new testing devices that are safe, high quality and more user-friendly than existing testing devices.
“The TGA needs to balance its responsibility to rigorously assess the quality of medical devices against the need to make them available,” said Dr Bridget Haire, National President of AFAO.
“With HIV self-testing, the sooner we get these devices into the hands of people at higher risk of HIV, the faster we can reduce the rate of HIV transmission.”