US approval of Brisbane company's COVID test kit 'very pleasing'

Brisbane-based biotech company Ellume has been awarded FDA approval in the United States for its home COVID-19 test to be rolled out.

The kits will not require a prescription and will be able to be bought over the counter at pharmacies, a move that will expand, it is hoped, testing options for people as coronavirus continues to run rampant through the country.

Dr Sean Parsons, founder of Brisbane biotech company Ellume, which has been given US FDA approval for its rapid COVID-19 home test kits.

Developed and wholly manufactured in south-east Queensland, Ellume’s tests are self-contained and can deliver a result in as little as 15 minutes, from a sample taken with a nasal swab.

Other tests that are collected at home have previously been approved by the FDA, but the sample has to be sent to a lab for analysis, while this test can be done entirely by the patient.

Ellume founder and CEO Sean Parsons said the company was very pleased by the FDA approval, which he said was a show of support for their testing platform.

“It’s exciting for Ellume. We’ve been developing our core technology for a long time, over a decade, and to see it being applied so swiftly to create a high-impact diagnostic product for COVID-19 is very pleasing,” Dr Parsons said.

Ellume's kits are used with a free phone app, and do not require samples to be sent to a lab, meaning it can generate a result in around 15 minutes.

“We are now working feverishly to ramp up our manufacturing to supply as many of those tests to the US as we possibly can.”

Despite the approval for use in the US, the tests will not be rolled out in Australia, which has a different regulatory framework.

Dr Parsons said they will not be seeking regulatory approval for the product in Australia straight away, as the product was not needed here because of Australia's good handling of the pandemic.

“Australia has different testing needs than Europe and America, where there is far more COVID,” he said.

“Our product is best designed for those countries where the lab testing capabilities are swamped, so the US and Europe is where our product can have the highest impact.”

Infectious diseases expert Nigel McMillan from Griffith University said the kits have a 96 per cent overall accuracy rate, making them a valuable tool in the response to the pandemic, especially in the US.

“This is the sort of things that will not only allow home testing but, for example, the NFL are looking at these kits because they want to get crowds to their finals,” Professor McMillan said.

“So they’ll get people to home test and then people can use the test results to get into the stadium.”

He said Australia may not have as great a need for the kits, but there were specific examples where they could be very useful.

“I would think sporting codes, for example, would be knocking down the door to get their hands on these,” he said.

“The trouble is in Ellume’s manufacturing capacity – because the US government has chipped in funding for this, they get first choice and they’ll take all they can get.”

The US National Institutes of Health has invested US$30 million in the technology, and that allowed Ellume to fast-track its development.

The Queensland government announced late last week it would contribute an unspecified amount of funding to Ellume as part of its $50 million Essential Goods and Supply Chain program.

The money is not for the test kits program specifically, Dr Parsons said, but would allow them to bolster their supply chain as they ramped up production of this product as well as a number of other products they manufacture.

All of Ellume’s output comes from its factory at Richlands, with the company already able to produce 100,000 of the test kits per day, and plans are under way for that to ramp up to 200,000 per day by March 2021.