Brisbane’s Ellume steps up its rapid Covid-19 tests in the US

A lack of government funding for GPs to perform Covid-19 and flu tests means the US is first in line for Ellume’s rapid point-of-care tests.

Ellume’s production facility in Brisbane. Picture: AFP

Brisbane biotech Ellume is stepping up the expansion of its rapid Covid-19 tests across the US in a case where ‘America’s gain is Australia’s loss’.

It has secured approval from the US Food and Drug Administration to sell its test – which can detect Covid-19 in as little as three minutes – to point of care providers, such as doctors and pharmacists, as well as major commercial venues, including stadiums and airports.

The news comes three months after the FDA authorised Ellume’s over-the-counter Covid tests, which Australian legislation currently bans. Only point-of-care providers can administer Covid tests in Australia.

Health Minister Greg Hunt said Ellume was welcome to apply to the Therapeutic Goods Administration (TGA) to deploy its point-of-care tests across Australia. But Ellume chief executive Sean Parsons said local point-of-care testing was a small market.

In the US, the government reimburses doctors for point-of-care testing, whereas in Australia GPs don’t receive a rebate for influenza or Covid testing.

“In Australia if a GP wants to do a Covid test, then they will either need to pass that cost on to the patient, or they will need to absorb the costs in the clinic. So the reimbursement structure in Australia makes it a small market for point-of-care testing,” Dr Parsons said.

“We are preparing to submit the product to the TGA for the review. So yes, it’ll come in due course. But the US is obviously our main game from the commercialisation side.”

Dr Parsons said funding arrangements for doctors performing Covid tests in Australia were counterproductive, particularly as testing sites were becoming overwhelmed as governments urged more people to get tested to contain outbreaks.

Ellume chief executive Sean Parsons at his Brisbane warehouse. Picture: Glenn Hunt

Such is the pressure on sites that NSW Treasurer Dominic Perrottet last week apologised to residents in Sydney’s west who were forced to queue for more than four hours for a test.

Under the NSW government’s new rules – aimed at limiting the spread of its latest outbreak, which has plunged Australia’s most populous state into an extended lockdown – people living in Fairfield in western Sydney who need to leave the area for work must take a Covid-19 test every three days, regardless of whether or not they have symptoms.

In Melbourne – which has entered its fifth lockdown after last year’s 140-day epic – Covid test wait times were more than two hours, with some sites even turning people away.

“As the pandemic moves on into a new normal, I think we need to consider what the trajectory is out of and beyond these lockdowns, and beyond the international quarantine,” Dr Parsons said.

“We can’t keep Covid at bay forever. And so when we get into that new normal where Covid is then circulating in the community … there will still be some people who are vaccinated that still get Covid. And in those cases, we need to identify those people early in the course of the illness and get them connected into the medicines when they’re available.

“So point-of-care testing is going to need to be part of the future to really manage this pandemic indefinitely – manage a world where coronavirus is part of life.”

The US government has embraced Ellume, which has taken strategic advice from Joe Hockey’s Bondi Partners.

In February Ellume won a $US235m ($316m) contract from the US Department of Defence for the rollout of its rapid Covid-19 test. That followed the US National Institutes of Health granting the company $US30m to ramp up production.

The company has now extended its manufacturing capability to the US, building a factory at Frederick, Maryland – about an hour from Washington DC.

“The fitout is under way at the facility.

“We will get to make the first product in the fourth quarter of the year and start really extending our manufacturing capacity into the US,” Dr Parsons said.

“Obviously that facility is partly about responding to this pandemic but it’s even to a greater extent about future capability to respond to future pandemics, recognising that these threats are likely to be ongoing.”