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‘A scramble’: how Australian governments flipped from resisting to embracing Covid rapid antigen tests

The Guardian
The Guardian
 2021-12-31
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Covid rapid antigen tests on a table as a health worker administers them in Melbourne. Australia’s pathology industry – a huge financial beneficiary of PCR testing – has lobbied hard against the use of the tests.

In the past few weeks, Allison Rossiter, the managing director of Roche Diagnostics, one of the first companies to have an approved rapid antigen test in Australia, has witnessed a flurry of interest from state governments.

South Australia, which until a week ago had banned the use of the tests, is among their new clients. So too is Western Australia, which placed an order with the company this week despite the tests still being banned in the state.

“We have massive orders in for rapid antigen tests for Western Australia,” the WA premier, Mark McGowan, said on Wednesday. “We expect to have 8 million by 5 February and we expect to get more after that.”

It hasn’t always been this way. Interviews with manufacturers and suppliers of rapid antigen testing reveal a frustration at the amount of resistance to their products in Australia until very recently.

“The response from government has generally been ‘yeah we’ll look at it’ or ‘maybe in the new year’, but until now there hasn’t been any critical impetus,” Dean Whiting, the chief executive of Pathology Technology Australia, a group representing rapid antigen testing suppliers, told Guardian Australia.

“There has been some confused market messaging at times and I think there is a level of frustration.”

Since the beginning of the pandemic, Australia has bet heavily on PCR testing as a key plank of the country’s Covid testing and tracing system. More reliable than rapid testing and cheaper for the states to operate because it is subsidised by the commonwealth, it has meant suppliers of the faster turnaround tests were de-prioritised in the Australian market, while demand in Asia, Europe and the US soared.

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“At the beginning we had no idea whether rapid testing was going to fly in Australia at all,” Rossiter said.

“There was a lot of, I don’t want to say misinformation, but a lack of information about the tests or how they differed from PCR tests, and so it was hard to know.

“I don’t know if it was necessarily from government per se but I think in the medical profession the experts were certainly dubious.”

The pathology industry, which has been a huge financial beneficiary of PCR testing, lobbied hard against the use of the tests. During the pandemic the Royal College of Pathologists of Australasia, the body that represented pathologists, has issued numerous statements warning against their use.

In October last year it point-blank advised “against the widespread use” of the tests, a position it reaffirmed as recently as July.

While Roche has been well-placed to fill most orders, reports of market shortages in pharmacies and shopping centres, as well as accusations of price gouging, point to a wider view in the industry that the Australia market was not worth investing in until very recently.

Some companies, such as Brisbane-based Ellume, have not even bothered registering their products with the Therapeutic Goods Administration in Australia and instead ship their kits – which they produce about 100,000 of each day – straight to the US.

“Part of the challenge for manufacturers is how much Australian product do you bring in and hold when you’ve had state governments up until very, very recently being unsupportive of rapid testing and at times even dismissing it,” John Kelly, the managing director of testing company, Atomo, said.

“I suspect stock in Australia at the moment is probably less than is required to do the job and in large part that’s due to a lack of engagement, planning and preparation to get ready for this.

“I’m always wary of judging a pandemic with hindsight because things are unpredictable, but certainly governments here have been resistant to point-of-care testing from the very start and there has been resistance in public health because of the diagnostic advice coming from the pathology sector.”

It was only in August, when the outbreak in New South Wales saw the government pivot to rapid tests to keep some industries in operation, that the college conceded “governments and public health authorities fighting localised outbreaks may need to use RATs for surveillance testing in defined circumstances”.

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It was in that period that Rossiter’s company, Roche, began circulating a white paper to state health departments in an effort to push back on the theory that the tests were not safe for use in Australia and encourage departments to think about a future that would require more wide-spread testing than PCR allowed.

“It was a gamble, but I didn’t want us to be on the back foot,” Rossiter said. “Australia is obviously a million miles from anywhere and I didn’t want to be caught out if the situation did change.

“As it happened, the sudden uptick in cases due to Omicron and that coinciding with the Christmas period all snowballed at once and now you do have a situation where there is a bit of a scramble from governments.”

Part of the issue has been the slow pace of approvals with the TGA. In September the TGA boss, John Skerritt, admitted that had been deliberate, as the regulator waited for a “signal” from the federal government.

“We’re saying to companies, submit your data, show us, but we can’t formally make an approval decision until we get a signal from the government,” Skerritt said at the time.

“It’s a decision for the government. Firstly, when they feel an appropriate time is to commit such tests. But then secondly, we’ve got to have the tests that are actually ready to go and designed so they can be used by non-professional people.”

That signal eventually came when federal health minister, Greg Hunt, said he wanted rapid tests to be made available from November.

But other suppliers express frustration that the approvals process has continued to be slow-going, and a lack of foresight from governments about the eventual need for rapid tests as case numbers rose after the economy opened up.

During the early stages of the extended lockdown caused by the Delta variant, the NSW government issued a tender for suppliers of the tests.

Released at the end of July, the tender was limited only to procurement for the state’s healthcare networks, meaning wider distribution was not considered.

The Guardian understands the government eventually chose four suppliers as part of the tender, but multiple companies that bid during the tender were never contacted after submitting their bids.

“It was a waste of time,” the head of one company that did not bid as part of the tender said. “They obviously weren’t looking beyond the end of their noses.”

NSW Health did not respond directly to questions about the tender, but said the government had “made a commitment to make rapid antigen tests available to NSW residents early next year to boost the Covid-19 health response across the state”.

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