When Brisbane based company, AnteoTech began developing RATs in Australia, Devon Thomson, CEO of AnteoTech stated that the government did not support the use of RATs in Australia. Leading the company to focus on exporting the product to Europe.
"We obviously could have poured a lot of money into the Australian market but, when we looked at it, the governments had a stance or policy that they weren't going to use RATs," Mr Thomson explained.
"There was really no indication that the governments were going to change their policies or stance around the use of RATs."
As such, AntoTech has no supply available to Australia.
Another Brisbane-based company, Ellume, also looked offshore to market its RAT for similar reasons and are already selling millions of tests to the US.
Ellume’s executive chairman, Sam Lanyon, told ABC News that his company approached the federal and state governments about a year-and-a-half ago advocating the local production of COVID RATs.
His advice, he said, fell on deaf ears, with Australian governments preferring "gold standard" PCR tests over rapid antigen tests.
They are now seeking regulatory approval for its tests in Australia, however the TGA approvers appear to be “dragging their feet” leaving RATs “ineligible” for use in Australia, despite being used in Europe and the U.S.
However, the TGA states that delays are typically with manufacturers - not the TGA.
"For most applications received by the TGA, there is missing information that requires multiple requests being issued by the TGA.
"Many applicants fail to read the TGA requirements or do not have the evidence to demonstrate their test performs at the sensitivity rates that they claim, or that is required.
"This could be a serious issue if the test does not perform to detect COVID-19 or its variants."