Queensland startup Ellume has secured FDA approval in the US for its rapid home-testing kit for COVID-19.
The Aussie-built tech pairs a nasal swab with a smartphone app, which displays results within about 20 minutes, allowing for fast self-detection and stemming the spread of infection.
Trials demonstrated 96% accuracy for both symptomatic and asymptomatic people.
The non-prescription product is suitable for both adults and children as young as two, and has been granted Emergency Use Authorization by the US Food and Drug Administration.
The startup secured a $30 million grant from the US National Institutes of Health Rapid Acceleration of Diagnostics initiative, allowing it to fast-track development of the test.
Now, it’s ramping up production, and is on track to manufacture more than 100,000 tests per day in January.
The approval is a “major milestone in diagnostic testing for COVID-19”, FDA commissioner Stephen Hahn said in a statement.
Ellume founder and chief Sean Parsons sees the tech as an “important first line of defence”.
“It can be widely available without the need for a prescription, enabling the US to respond to the pandemic in its most urgent stage.”
The Aussie medtech has been working on digital diagnostics for the past 10 years.
Founded in 2010, Ellume has been working on digital diagnostics tools allowing people to detect the flu using their phones.
Headquartered in Brisbane, the startup has always viewed the US as its key market for expansion. Free healthcare in Australia makes patients less likely to self-test at home, Parsons said in an interview with SmartCompany last year.
In June 2020, the business raised $5 million in funding, focused on commercialising and developing its products, while ramping up for a listing on the ASX.
At that time, Parsons said the device is intended to empower people to manage their illnesses themselves. At the same time, it was always focused on health education, and containing contagious diseases.
Self-diagnosis also reduces the burden on national resources, Hahn explained.
“We are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies.”
Back in 2019, Parsons was focused on telemedicine and connectivity, he said. Speaking just months before the beginning of the COVID-19 crisis, he couldn’t have known just how important these concepts would become in 2020.
“We make those results and the data that comes out of our diagnostics as useful as possible,” the founder said.
“That puts us in this crossover of being a diagnostics business and a digital business.”