FDA approves Brisbane-based company Ellume’s product, the first at-home coronavirus test that does not require a prescription
A rapid, over-the-counter Covid-19 test developed by Australian firm Ellume has been given emergency approval in the United States.
The US Food and Drug Administration (FDA) approved the Brisbane-based company’s 20-minute Covid-19 Home Test on Tuesday as the US battles the virus that has infected 16.5 million people and killed more than 300,000 people in the country.
The agency approved a prescription coronavirus test last month, but an over-the-counter product will make it easier to ramp up testing.
“By authorising a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” the FDA commissioner, Stephen Hahn, said in a statement.
“As we continue to authorise additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”
The Ellume Covid-19 Home Test uses a special nasal swab connected to a smartphone app, which sends the results back to users via bluetooth in as little at 15-20 minutes.
To use the app users must enter a postcode and their date of birth, which can be shared with health authorities to monitor outbreaks and conduct contact tracing.
The FDA says Ellume’s test correctly identified 96% of positive samples and 100% of negative samples in patients with symptoms.
In asymptomatic patients, the test identified 91% of positive samples and 96% of negative samples.
“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” the FDA’s Jeff Shuren said.
“However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”
With the pandemic already killing more than 2,400 Americans a day and 111,000 patients being treated, Ellume is already ramping up production.
The company expanded its manufacturing facility in Brisbane after being awarded a US National Institutes of Health’s rapid acceleration of diagnostics grant worth $30m in October.
“As Covid-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” the Ellume founder and chief executive, Dr Sean Parsons, said.
“Ellume’s Covid-19 Home Test delivers this 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 company said it would ship more than 100,000 tests to the US next month and plans to manufacture 20m tests in the first half of 2021.