Top story on the ABC site.
Australian-made RATs await TGA approval amid rapid antigen test shortage
By business reporter
Michael Janda
Posted 1h ago1 hours ago
Several Australian companies are still awaiting TGA approval of their rapid antigen tests.(AAP: Lukas Coch)
As Australians struggle to get hold of a COVID-19 rapid antigen test, several Australian companies have been waiting months for local approval of their RATs.
Key points:
- At least two Australian companies have applications pending with the TGA for rapid antigen tests
- Both tests are currently in use in overseas markets
- Brisbane-based AnteoTech is hoping to produce at least a million tests a month from its Brisbane factory, within months
Currently, only one of the 22 home tests approved by Australia's Therapeutic Goods Administration (TGA) is made locally, with 16 sourced from China, two from the US and the others from Korea, Singapore and Germany.
However, with the global Omicron wave seeing surging demand for RATs around the world, there are concerns
Australia's current supply shortage could be exacerbated if planned shipments are diverted elsewhere.
In particular, with the vast bulk of Australia's tests coming from China, a worsening Omicron outbreak there could further threaten supply if tests bound for export were requisitioned by the Chinese government.
Several Australian companies have developed COVID RATs locally, although at least two are waiting on TGA approval for tests that are already in use in Europe or North America.
Brisbane-based AnteoTech is one of those.
Its chief executive Derek, Thomson, told the ABC that a lack of supply was inevitable during major waves of new COVID variants such as Delta and Omicron without much earlier planning and investment by Australian governments.
Derek Thomson, CEO of AnteoTech, says Australian governments were not interested in RATs until the Delta outbreak locally.(Supplied: AnteoTech)
"We were always going to run out of supply, and that's exactly what happened over the Christmas period," he said.
"It caught the governments on the hop, caught all the manufacturers on the hop.
"And so we're in the position that we're in. We've got a massive wave, we're saying that the frontline defence to that wave is rapid antigen testing, and no-one can buy one. So it's a disaster."
AnteoTech has received some government funding, such as a $1.4 million commitment from the Queensland government earlier this year and a nearly $2 million refund under the federal Research and Development Tax Incentive Scheme.
However, despite the financial support, the lack of government support for using RATs in Australia meant the company's focus shifted 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."
Another Brisbane-based company, Ellume, also looked offshore to market its RAT, already selling millions of tests to the US government and through retail outlets there, although the ABC understands it is now also in the process of seeking regulatory approval for its tests in Australia.
Sam Lanyon is the executive chairman of Melbourne-based Lumos Diagnostics, another company whose tests are awaiting TGA approval.
Sam Lanyon, executive chairman of Lumos Diagnostics, says the company urged Australian governments to support local RAT production as early as mid-2020.(Supplied: Lumos Diagnostics)
He told ABC News that his company approached the federal and state governments around a year-and-a-half ago advocating the local production of COVID RATs.
"It does take time to set up manufacturing, to validate your facility, get your product into manufacture and then out the other side, and then start supplying it to global market," he explained.
"So mid-2020 the company was providing proposals around, if you start to focus on the recovery phase, we need 12 months of time to get everything in place so that we actually have domestic capability in place."
His advice, he said, fell on deaf ears, with Australian governments preferring "gold standard" PCR tests over rapid antigen tests.
"For that reason, we set up our manufacturing capability out of Florida and California, which is there today, providing our range of tests into the US, European and Canadian markets at this point in time," Mr Lanyon said.
Policy about-face left suppliers flat-footed
That was before a sudden about-face during the Delta outbreak in New South Wales, Victoria and the ACT, when the federal government changed legislation to allow for the approval of at-home testing not performed by health professionals.
"We were just quite surprised how fast it changed based on the needs of the pandemic, and Delta coming along, and driving a whole bunch of legislative changes that I think fundamentally would have been good to be in place back when we started the company [in 2015]," said Mr Lanyon, whose firm had, until then, been focusing on RATs administered by healthcare professionals.
Lengthy lines of people on foot or in cars waiting for COVID PCR tests in the period around Christmas convinced governments to broaden the use of RATs.(ABC News: Tim Swanston)
Both men said these sudden, belated policy changes have left Australia far behind.
"We are now in a position where the government has realised that RATs are a frontline tool for managing the pandemic, and that same situation was realised by a number of other major markets much, much earlier," Mr Thomson lamented.
AnteoTech's decision to focus on Europe means it already has tests being produced in Spain, some of which it plans to divert to Australia once it gets regulatory approval for its RAT domestically and until it can get its Brisbane factory up and running.
"We can manufacture, currently, a small volume of tests here," Mr Thomson said.
"We've ordered, and will be delivered very shortly, a set of equipment that will enable us to build 12 million strips per year, and we'll have that up and running in the second quarter this year.
"Our plan now, as Australian governments have indicated that RATs are going to be a frontline tool for the pandemic, is to scale up manufacturing here in Brisbane significantly over the next nine to 12 months.
"And we anticipate that we will be able to produce multiples of that 12 million during the next 12 months to provide a real sovereign manufacturing capability for the Australian market."
TGA approval delays
The key hold up now is local regulatory approval for AnteoTech's test, already approved for use in Europe many months ago.
Despite the change in government position on RATs, and the critical shortage of tests, getting approval from the TGA is proving difficult.
AnteoTech lodged its application in September, as did Lumos Diagnostics; both have been asked to submit further information.
"We're working with the TGA on adding some additional clinical data to the application," Mr Lanyon said.
Mr Thomson said his company's Australian application coincided with much tougher evidence requirements than when AnteoTech's test was approved for use in Europe.
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"Globally, regulatory authorities have tightened their requirements for approval of rapid antigen tests, because the Chinese tests, a lot of tests, have flooded the markets with poor-performing product," said Mr Thomson.
"At the point we put in our approval application, they [the TGA] had tightened them again ... so we had to top up our data for them along the process."
For its part, the TGA told ABC News that delays usually rest with the test manufacturers.
"Generally, if all required information is submitted, approval can occur between 3-5 days," it said in a statement via the federal Department of Health.
"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."
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In the case of the three Australian companies, the TGA said it was waiting on them.
"We can confirm that, at the request of two of the named companies, we have provided several months for them to submit the required evidence and is [sic] still waiting on this evidence from these companies," the statement noted.
"In relation to the third company — we do not have an application for their COVID test strip. Therefore the TGA cannot assess information it has not received."
The TGA said it was continuing to "prioritise and expedite the assessment of COVID-19 rapid antigen self-tests for home use as quickly as information is received from applicants."
AnteoTech said it was expecting to submit further fresh data to the regulator next week, but was not anticipating immediate approval in response.
"We haven't met anybody who's gone through in three to five days," responded the company's CEO Derek Thomson.
"I'm hopeful that we're in the final stages now."
TGA approvals 'far more stringent than Europe'
Despite the frustration of not being able to sell their tests into the Australian market yet, neither of the men are critical of the TGA.
"Europe was relatively quick. I think if you look at the number of registered products in Europe, and there's a huge number of manufacturers providing product there," observed Mr Lanyon.
"It's a self-certification process using a commercial regulatory auditor, so it is by far a faster approach and, to some extent, the regulators outside of Europe would say, potentially less rigorous approach as well.
"That, by its very nature, exposes the population to some level of risk in terms of selecting the right product and making sure that they've got a good, reliable product.
"I'm comfortable with the way that the Australian TGA is going about it, as well as Health Canada. I think they've approached it in the most appropriate manner."
Mr Thomson agreed.
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"The TGA approval process is far more stringent than the European process," he said.
"The European process is going to change in May of next year to a process that's similar to what the TGA have adopted."
He acknowledged that there was little the TGA could have done to speed up approvals without compromising on its standards.
"We were caught up in a scenario where they were just trying to do a lot really quickly," he told ABC News.
"They could have done a lot of things to speed it up. But that would have meant them reversing some of the requirements that they made tougher."
As for the general delays in Australian policymakers accepting rapid antigen testing as an important part of the fight against COVID-19, Mr Lanyon was philosophical.
"I'm just looking forward to, hopefully, getting local capability here so that, as the recovery phase and potential future pandemics come along, we're better prepared," he said.
"It could have happened earlier, but I think what we should be focusing on is just getting that in place as fast as possible."
Posted 1h ago1 hours ago
(20min delay)