A private Brisbane company called Ellume has sent one million home-testing kits for COVID-19 to the United States.
It’s making 30,000 of them a day, in Brisbane, entirely for the US market, where they are being sold in pharmacies for $US30 ($39) each.
What’s more, Ellume has just announced a $US231.8 million deal with the US Department of Defence and has received a $US30 million grant from the US government to build a factory in America to make the tests there.
So why is this Australian company selling all of its COVID home-testing kits in the US and none in Australia?
Bureaucracy, and politics.
In this country, there is a law against self-testing notifiable diseases, on the grounds that patients wouldn’t properly notify the authorities that they have it, or at least that notifications would be haphazard.
COVID-19 is obviously a notifiable disease, so testing yourself for it is illegal.
In 2014 HIV was exempted from the ban, and a US company OraSure now sells HIV self-testing kits in Australia.
In 2019, the Therapeutic Goods Administration started a public consultation to review the legislation, and that resulted in some additional diseases being added to the list of exemptions, including the flu.
Nine years earlier, in 2010, an intensive care and emergency clinician in Brisbane named Sean Parsons started a company called Ellume with the idea of creating a self-testing device for the flu in anticipation of it being allowed.
He did come up with a flu test that works, and has now partnered with the pharmaceutical giant Glaxo Smith Klein to manufacture them. He expects to start selling them in Australia later this year.
He has also created a self-test for tuberculosis; his partner for that is another pharmaceutical giant, Qiagen.
While he was working on the flu and TB, the 2020 pandemic hit and he refocused Ellume’s research onto COVID-19.
It worked: Dr Parsons says his test is 96 per cent accurate in detecting the virus that causes it.
So naturally he tried to get it put on the list of diseases exempted from the ban on self-testing notifiable diseases, so he could sell the tests in Australia – but he was knocked back.
In response to a series of questions, a spokesperson for Health Minister Greg Hunt told me this week (after the minister had gone to hospital) that “the advice from our medical experts is that testing for COVID-19 should only be conducted in an accredited pathology laboratory, or by a suitably qualified healthcare professional at the point of care”.
“In a low COVID-19 prevalence environment such as Australia, the risk of false positive results in rapid antibody or antigen tests (such as the Ellume) is higher than in high-prevalence environments such as currently exists in the US”.
So in Australia, Ellume’s COVID-19 test remains prohibited unless a health professional does it.
Epidemiologist Professor Marylouise McLaws told me that false positives for COVID-19 are not a problem.
“It’s a no-brainer,” she said.
“Why wouldn’t you use home testing to screen for COVID-19? If it’s a positive, even if it’s false, you just go and get a full PCR test.
“I think there is an important role for these types of rapid antigen tests.
I don’t understand the government’s reluctance.’’
With the Australian market closed, Dr Parsons decided to try the US, and reached out to none other than Joe Hockey to help.
The former Liberal treasurer and US Ambassador is a founding partner of “strategic consulting” firm, Bondi Partners, which Ellume engaged.
Late last year Dr Parsons sent a box with two prototype test kits to Hockey’s apartment in Washington.
Soon after that, Mr Hockey was playing golf in DC with “a person who carried influence with the US government”, as he later put it, and told the golf partner about the tests. He was interested.
The following Sunday Mr Hockey dropped the box off at his golf partner’s house.
Swift action then ensued.
In November the US Food and Drug Administration issued an “Emergency Use Authority” (EUA) for Ellume’s COVID-19 self-tests and the company made the first batch in Brisbane in January.
The first shipment was dispatched to the US at the end of January, and six weeks of frenetic activity later, they’re up to one million tests on US shelves at $30 a pop.
The US facility, when it’s built, will be able to service the US market with a capacity of about 500,000 tests per day.
The capacity of the Brisbane factory will also be increased to 150,000 per day – for the Australian market, Dr Parsons hopes, when they’re eventually allowed to sell them here.
That seems optimistic, given the minister’s reply to me this week.
There would have to be another review of the notifiable diseases legislation by the TGA and the medical advice to the minister on self-testing for COVID-19 would have to change.
Better still might be removing the whole matter of self-testing notifiable diseases from politics and leaving it to the TGA.
The regulator has the skills and authority to make all decisions about testing for disease and doesn’t need to be second guessed by the minister.
The TGA should be allowed to issue Emergency Use Authorities like the FDA does in the US.
An obvious reason for the difference in urgency between the two countries, as referred to by Mr Hunt’s spokesperson, is that Australia now has no community transmission and the US is still recording more than 45,000 new cases per day.
That also helps explain why the US has so far administered 100 million vaccinations, while a more relaxed Australia has managed only a few thousand.
But there is really no excuse for that: Australia’s performance on vaccination is abysmal, despite all the upbeat doorstops and press releases.
Will vaccines eventually mean home tests for the disease won’t be necessary, and won’t sell?
Dr Parsons says no – that there will always be outbreaks and COVID-19 brought in by visitors, and vaccines don’t prevent transmission, only illness.
So here we have a remarkable success story in Australian biotech … but only for an ICU clinician named Sean Parsons and the US, not for Australia.
Alan Kohler writes for The New Daily twice a week. He is editor in chief of Eureka Report and finance presenter on ABC News