TGA hurdle holding back millions of RATs from Queensland

There could be millions of rapid antigen tests flowing into Queensland by the middle of the year, if a local company can clear the regulatory hurdles that has left it sending its stock overseas.

AnteoTech is a Brisbane-based biotech company that has the capacity to make 12 million RATs a year.

Brisbane-based biotech company AnteoTech says it could be providing millions of RATs to Queensland if it gets TGA approval.Credit: Stuart Layt

The company’s chief executive Derek Thomson said they had approached the Therapeutic Goods Administration for approval for their tests in September last year but were yet to hear back.

It comes after the company approached the federal government early in 2020 as the pandemic began to ramp up, but Mr Thompson said they did not get much traction.

The company has a manufacturing plant in Spain that is producing millions of tests for the European and UK markets after the company was given regulatory approval there last year.

AnteoTech chief executive Derek Thomson.

Mr Thompson said at least some of those tests could have been sent to Australia if the regulatory hurdles had been overcome earlier.

“We could supply millions now, it’s a good volume and it would certainly make a dent in the Queensland need at the moment,” he said.

“We didn’t get a huge amount of traction at the time in a discussion nor did any other of the manufacturers by the way, and so you look at the likes of Ellume who have got a large manufacturing plant here in Brisbane, they went to the United States to sell their product, we went to Europe.”

The Queensland government contributed money towards both AnteoTech and Ellume to set up their manufacturing capability, but did not secure any supplies of RATs through those companies at the time.

Deputy Premier Steven Miles defended that decision, saying the tests had not been TGA approved and RATs were not needed at earlier stages of the pandemic when virus cases were comparatively low in Queensland.

However, Mr Miles said given the “rapid antigen testing emergency” Queensland and the rest of the country now found itself in, he was urging the federal government to now approve the tests as soon as possible.

“More than two weeks ago the Prime Minister said the market would fix it and it wasn’t the government’s job,” he said.

“The market has not fixed it and so we need the Commonwealth to do everything that they can to both get rapid antigen tests into Australia and to support sovereign manufacturers so that we can be making them here.”

Mr Thomson said despite the delay he was confident there would be some movement on the issue with the TGA in the near future.

“We’re supplying them some more information, we’ve continued to do that and we believe that we’re in the final stages of our of our processing,” he said.

“We would have liked it to go quicker but we understand that they have a responsibility and we’re working with them as best we possibly can.”