Why Aussie startup Ellume’s home-testing tech should help us in the COVID-19 recovery, but can’t

An Aussie medtech company is leading the charge in home-testing for COVID-19, but legislation means Aussies — and the small businesses that employ them — are not able to reap the benefits.

That’s according to Dr Sean Parsons, founder and chief of medtech Ellume, which has developed a COVID-19 home testing kit already in use in the US.

In an interview with the Australian Financial Review, Parsons suggested home testing for the virus should play a key role in returning to some kind of normality — that is, reopening borders and avoiding further lockdown situations.

“We must develop strategies for the new normal of living with COVID,” he said.

Before the COVID-19 pandemic, Ellume focused its growth strategy on the US market, with Parsons suggesting the healthcare system in Australia means people are less likely to self-test at home, and more likely to visit their GP.

However it appears there is also legislation in place in Australia blocking the Therapeutic Goods Administration from even reviewing submissions for tech that offers home testing for notifiable diseases.

But as pressure on testing sites leads to long wait times, and with essential workers in Sydney ordered to be tested every three days, home testing is starting to look like a more sensible option.

Parsons told the AFR that law was written when global pandemics weren’t really on the radar.

“They wanted to force people to record … those illnesses through the health system,” he said.

“I don’t think it really makes sense now.”

There are reportedly rapid testing kits in the works for high-risk essential workers, which have been approved by the TGA. However, a TGA spokesperson said rapid tests for home use are currently not allowed, because of a “high risk” of false positives and false negatives alike.

Ellume’s COVID-19 home-testing kit. Source: Ellume.

“An essential tool”

Founded in Queensland in 2010, Ellume has been working on digital diagnostics technology for more than ten years.

Its COVID-19 rapid home testing kit pairs a nasal swab with a smartphone app, and can display results within 20 minutes.

In December 2020, the kit was granted Emergency Use Authorization by the US Food and Drug Administration (FDA) in the US, after trials demonstrated 96% accuracy in both symptomatic and asymptomatic patients.

The following February, Ellume secured a contract with the US Department of Defense worth US$231.8 million ($304 million), to expand its production capability.

In a statement at the time, Parsons called the test “an essential tool for the broader pandemic response”.

Then, the US was recording more than 100,000 new COVID-19 cases daily.

“Our focus is enabling the US to minimise community transmission and reopen as quickly as possible,” Parsons said.

Now, while the numbers in Australia are mercifully much lower, the ongoing lockdowns in both Sydney and Melbourne show life is far from back to normal, and small and medium businesses are feeling the effects.

Parsons said this is really a question for federal health minister Greg Hunt.

“Right now, the TGA are not able to review a submission we make,” he added.

“Their hands are tied.”

Do you think home testing for COVID-19 would be a boost to the Aussie economy? What would it mean for your business and your employees? Let us know.