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Coronavirus Qld: Ellume's home COVID-19 test given US green light

Brisbane technology firm Ellume will increase its production to 200,000 home-testing kits a day to meet US demand after receiving FDA approval.

“We are buried in execution right now, manufacturing as many of these products as we can,” Dr Parsons told The Australian Financial Review.

“Our focus is on rapidly expanding our manufacturing capability and delivering on that to respond to the COVID pandemic. [An IPO] is not off in the never-never, but now we just have to deliver.”

My instinct is COVID is here forever, and there will be a need for community-based testing indefinitely.

— Sean Parsons, Ellume founder and CEO

All units are produced from Ellume's manufacturing facility in the south-west Brisbane suburb of Richlands. The company has received funding from the Queensland government, but no federal funding.

While the home-testing kit is less applicable in Australia, which is currently on top of the COVID-19 pandemic, Dr Parsons said he believed the product would be crucial in helping detect the virus for government, organisations and sporting teams for at least the next four years.

“My instinct is COVID is here forever, a little bit like the flu is here forever, and there will be a need for community-based testing indefinitely,” he said.

A person using the Ellume testing kit takes a nasal swab before mixing it with a processing fluid and a Bluetooth-connected analyser.

There is a short video on the free app, which has to be downloaded to a smartphone, showing how it is done.

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Unlike other home-testing kits, which require samples to be sent to a laboratory, Ellume's results are done in less than 15 minutes and then sent to the test subject's phone.

Ellume is not just riding the COVID-19 wave, as it has also developed home-testing kits for influenza and tuberculosis.

Dr Parsons, a former emergency doctor who quit his day job to set up Ellume, said the simple diagnostic test was hard to stuff up and had a 96 per cent accuracy rate for symptomatic and asymptomatic individuals.

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 about 15 minutes. 

“The FDA was very rigorous in their demands. What we had to prove is that people can do it correctly first time and is accurate. The bar for home testing is higher than for testing via doctors,” he said.

“We're very comfortable the vast majority of people will use the test correctly.”

He says while the product may be more suited to countries where the coronavirus is rampant, such as the US or Great Britain, he believes it will eventually be used in Australia once the national borders are opened.

“Eventually hotel quarantine will cease and there will still be people who bring coronavirus in,” Dr Parsons said.

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But at the moment the US government has first dibs on Ellume's output after investing $30 million in the new technology, which was inspired by Quidel's Sofia testing technology used by doctors and digital pregnancy tests.

Orders from other countries are expected to follow.

Dr Parsons said he was disappointed the Australian government showed no interest in the local technology.

The Palaszczuk government last week announced Ellume would receive an unspecified amount from its $50 million manufacturing fund, which would help it scale up its production.

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