US hungry for Ellume’s rapid COVID-19 tests, while Australia has no appetite for the technology

Brisbane-based Ellume has secured a new distribution deal in the US, amid stalled talks with the Morrison government.

CEO of Ellume Health Dr Sean Parsons. Picture: Glenn Hunt / The Australian.

Brisbane biotech Ellume says its conversations with the federal government about deploying its rapid COVID-19 tests have stalled, despite securing a distribution agreement to sell its test kits across thousands of US pharmacies.

US pharmacy chain CVS will start selling Ellume’s test — the first rapid, fully at-home test to receive emergency use authorisation from the US Food and Drug Administration for use without a prescription — across its network of about 10,000 stores.

But Ellume chief executive Sean Parsons told The Australian that its technology, which can detect COVID-19 in 15 minutes, continues to be out of reach for Australians, with the government expressing “little appetite” to make the regulatory changes required to allow rapid over-the-counter tests.

“We just fell as though we’re swimming against the stream on these issues here in Australia,” Dr Parsons said.

“There have been no further conversations with us and the federal government about any changes to legislation. While we would love to be able to support Australia, our focus is the US at the present time.

“We don’t feel there is the appetite at the federal level for change and acceptance of these new technologies. For whatever reason, they’ve kind of concluded that they’ve got what they need.”

In Australia the supply and advertising of self-tests for COVID-19 — without the oversight of a health professional — is prohibited under the Therapeutic Goods Act.

This does not prevent Ellume applying to have the tests administered by a health professional such as a doctor or pharmacist. But a spokeswoman for Health Minister Greg Hunt said Ellume had not sought such approval.

Dr Parsons — a former critical care doctor who specialised in emergency and intensive care medicine — said Ellume was sending “hundreds of thousands” of tests to the US every week, after the company secured $US265m ($340m) from the US government to accelerate the development of their tests and supply the US Department of Defense.

As part of the Department of Defense contract, Ellume is looking at sites in the US to build a new factory, which will complement its existing facility in Brisbane. Once up and running, Dr Parsons said the company will focus on other international markets, including emerging markets, where the threat of COVID-19 mutating and setting global immunisation efforts back is high.

“That’s where the risk really exists for COVID-19 to escape the vaccine and mutate to such that our vaccine coverage wasn’t what we thought it was.

“So Ellume will be looking to maximise our production capacity to deliver as many products as we possibly can into global markets.”

Dr Parsons said he was a “vaccine supporter” but testing was still a critical component of quashing the COVID-19 pandemic.

“We definitely want to see the world get vaccinated and get control of COVID-19. But we are still going to find people who choose not to get vaccinated. There are going to be people where the vaccine isn’t effective.

“And so the testing doesn’t slow down until we’ve really got control COVID-19 — not just in the developed world but also in those emerging markets where it’s going to be so easy for COVID-19 to get reimported back into places that have got on top of it.

“So testing is going to be with us for a while.”

Mr Hunt’s spokeswoman said: “the Australian government congratulates Ellume for their work in providing support to the United States through their COVID-19 outbreak”, adding it “not only provide jobs for Australians, but support for one of our closest allies”.

“This achievement was supported by $1m in Australian government funding in 2015 to assist them in commercialising their technology,” Mr Hunt’s spokeswoman said.

“Under Australian regulation, Ellume could supply their product for use at the point-of-care by certain suitably qualified health professionals. However to date Ellume has not sought approval through the Australian process for this purpose.”

Mr Hunt’s spokeswoman said Australia used the “gold standard” testing for COVID-19.

“In Australia, 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, where immediate clinical advice and treatment can be provided to the individual.

“It is one of the reasons why Australia has been a world leader in suppressing the virus, compared with other countries such as the US where there is a need for other forms of testing.

“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 United States.”

Two weeks ago Prime Minister Scott Morrison was forced to announce a “major recalibration” to the nation’s coronavirus vaccine program after the European Medicines Agency, which found a link between the AstraZeneca vaccine and a rare blood-clotting syndrome.

This prompted the Australian Technical Advisory Group on Immunisation to recommend the Pfizer vaccine be given preference over the AstraZeneca jab for those aged under 50. A week after the switch, the Therapeutic Goods Administration revealed the death of a 48-year-old NSW central coast woman was linked to the AstraZeneca vaccine.

The government has since ordered an extra 20 million doses of the imported Pfizer vaccine. It was initially expecting to vaccinate most Australians with the AstraZeneca jab after contracting CSL to manufacture more than 50 million doses in Melbourne.

Originally published as US hungry for Ellume’s rapid COVID-19 tests, while Australia has no appetite for the technology