A new home COVID-19 test, which started as an idea at Caboolture Hospital 10 years ago, has this week been given emergency use authorisation by the US Food and Drug Administration (FDA).
The non-prescription test has shown 96 per cent accuracy in studies and Brisbane company Ellume is preparing to ship 20 million home tests to the US in the next six months.
It has been developed by Dr Sean Parsons, founder and CEO of Ellume, from his time in the Caboolture Hospital emergency department during the 2009 Swine Flu pandemic.
Dr Parsons, now 40, recognised the growing need for fast, cheap diagnostics and started developing a rapid flu testing system.
He continued at Ellume, and when COVID-19 arrived the original testing kit was adapted and uses a smartphone app for results with minutes.
This week the Ellume COVID-19 Home Test became the first of its kind to be granted an EUA and is seen as an essential new tool to combat the pandemic.
“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” said Dr Parsons.
“Ellume’s COVID-19 Home Test delivers this important first line 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 user follows step-by-step video instructions on a dedicated smartphone app to do the home test, which involves a nasal swab. The sample is analysed and results supplied to the smartphone in 15 minutes or less.
With technology developed over the course of a decade, it can be used by adults and children aged two years and above, with or without COVID-19 symptoms.
Ellume said in data submitted to the FDA by an independent clinical study on 198 people aged from two to 82, its COVID-19 Home Test showed 96 per cent accuracy.
Ellume has expanded its manufacturing in Brisbane and supply chain in the US and will be shipping more than 100,000 tests a day across the Pacific from next month.