Australia’s TGA Will Allow More Self-Test IVDs
September 30, 2020
Australia plans to make more in vitro diagnostic (IVD) self-tests available for infectious diseases, the Therapeutic Goods Administration (TGA) said.
Beginning Oct. 1, the supply of IVD self-tests for a number of serious diseases and conditions will be allowed, including for hepatitis B and C virus, diabetes, kidney disease and cardiovascular disease, among others.
IVD self-tests will also be allowed for the seasonal strains of influenza virus but not for strains that are novel or emerging, such as the coronavirus pandemic strain. Self-tests for cancer and genetic testing will not be allowed to be sold to consumers, the agency said.