The agency says self-testing will help reduce the spread of COVID-19 through rapid self-detection, allowing patients to instantly isolate themselves.
Dr. Sean Parsons founded Ellume after working on the swine flu pandemic and said it was a pleasure to see the company’s hard work pay off.
“It is a new technology that was created here in Brisbane for a long time,” he said.
“It’s great to see this FDA approved product in these tumultuous times to help respond to the coronavirus.”
Developed and manufactured in South East Queensland, Ellume tests are self-contained and can deliver a result in as little as 15 minutes.
It works by applying a nasal swab to the test device, which is then connected to a smartphone that uses a free app to analyze and deliver a result.
“What we have been able to do is miniaturize a large instrument on this device, which connects via bluetooth to your phone and does all the analysis for you,” said Dr. Parsons.
“The innovation that we have offered is to be able to offer a high performance and good price instrument that can be introduced in a consumer market.”
FDA Director Stephen Hahn hailed the authorization as a major milestone in diagnostic testing for COVID-19.
“By authorizing a test for use without a prescription, the FDA allows it to be sold in places like pharmacies, where a patient can buy it, clean their nose, run the test and see the results in as little as 20 minutes,” he said.
“As we continue to authorize additional testing for home use, we are helping expand Americans’ access to testing, reducing the burden on testing laboratories and supplies, and providing Americans with more testing options from the comfort and safety from their own homes. “
Despite approval for use in the US, the tests will not be implemented in Australia, which uses a different set of regulations.
Dr Parsons said that due to Australia’s good handling of the virus, the product would not be needed here.
All of Ellume’s devices come from its factory in Richlands, Ipswich, which currently produces 100,000 test kits per day.
Plans are now being developed to increase production to 200,000 a day by March next year.