TGA Press Release on Rapid Tests
Australia’s health regulator the TGA has stated: Rapid Antigen Test cancellations not due to the failure to detect the COVID-19 Omicron variant. Follow the link to view the TGA’s media release. https://lnkd.in/g2njPrz3
Rapid Tests
Recent commentary questioning the performance of rapid antigen tests (RATs) against subvariants of Omicron is dangerously misleading and risks undermining Australia’s public health response according to Pathology Technology Australia https://www.abc.net.au/news/2022-07-29/rat-manufacturer-rapid-tests-covid-inaccurate-pcr/101282486
Minomic MiCheck® Prostate Test now Available for Australians
Minomic International Ltd has announced their MiCheck® Prostate test for detection of aggressive prostate cancer is now available at selected Sonic Healthcare Australia Pathology laboratories. Minomic CEO Dr Brad Walsh says the availability of the test will help Australia’s urologists provide better patient care, stating that “the use of MRI …when combined with results from…
TGA delays the IVDR Deadline to May 2023
The European IVDR device registration changes impact IVDs manufactured in Europe. These changes bring medical device quality certification, registration into line with practices already adopted in other parts of the world (especially north America and Australia).
