The boss of the Brisbane-based biotech shipping at-home COVID testing kits to the US says it may have to move production outside of Australia, as it rushes to deliver millions of units next year.
Ellume made global headlines on Wednesday after securing emergency use authorisation for its rapid coronavirus tests in the US, with plans to ship 20 million testing kits into the country next year.
It has received $US30 million ($40 million) from the US government to help develop the coronavirus tests, which are designed to be bought over-the-counter without the need for a prescription and can deliver results via a smartphone app in 15 minutes.
The company’s founder and chief executive Dr Sean Parsons warned that while companies like Ellume were focused on producing goods locally, Australia faced a significant challenge to keep home-grown medical technology manufacturers onshore.
Ellume will be manufacturing its at-home test kits from Brisbane to ship into the US. However, Dr Parsons said given the rising demand for the product the firm was mulling ways to expand its operations, including moving some production out of Australia.
“The company is evaluating lots of options, including in the US,” he said.
Building manufacturing facilities is capital-intensive and government support is important to helping foster this innovation, he said.
“There is certain to be another pandemic. When that next comes, we need to be better prepared to respond.”
Ellume received a $50 million cash injection from the Queensland government earlier this month to help it expand its manufacturing capabilities in Brisbane. Dr Parsons said that while there had been help offered from state governments, there was less support for companies like it at a federal level.
“The big challenge is keeping manufacturing technology businesses in Australia. There is lots of pull to move manufacturing overseas, and when the IP and manufacturing moves overseas, there is little value left for our [Australia’s] community.”
While Ellume’s technology is home-grown, it’s unlikely Australians will see the product on local shelves any time soon. Current regulations of at-home testing kits don’t allow for self-administered COVID-19 tests to be sold in Australia.
Dr Parsons said even if that changed in the future, the local market is not Ellume’s focus because Australia’s current management of the pandemic has meant there is little use for at-home tests at this stage.
“Australia doesn’t need a home COVID test right now. Australia needs to keep doing what it’s doing.”
US regulators have welcomed the approval of the test. Stephen Hahn, the head of the FDA, hailed the test’s authorisation as “a major milestone in diagnostic testing for COVID-19” in the US.
The authorisation for Ellume’s test comes in the same week that the US regulator is expected to approve the Moderna coronavirus vaccine. Alongside vaccinations, health experts believe rapid at-home testing will provide a crucial tool to bring the pandemic under control.
“By authorising a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” Hahn said in a statement.
Ellume, which was founded in 2010, is also working on a at-home test for influenza. It raised $5 million in mid-2019 with plans to list on the Australian Stock Exchange and Dr Parsons said those plans are now on hold as the company looks to fulfil the orders headed for the US.
Source: Thanks smh.com