Developed and wholly manufactured in south-east Queensland,Ellume’s tests are self-contained and can deliver a result in as little as 15 minutes,from a sample taken with a nasal swab.
Other tests that are collected at home have previously been approved by the FDA,but the sample has to be sent to a lab for analysis,while this test can be done entirely by the patient.
Ellume founder and CEO Sean Parsons said the company was very pleased by the FDA approval,which he said was a show of support for their testing platform.
“It’s exciting for Ellume. We’ve been developing our core technology for a long time,over a decade,and to see it being applied so swiftly to create a high-impact diagnostic product for COVID-19 is very pleasing,” Dr Parsons said.
“We are now working feverishly to ramp up our manufacturing to supply as many of those tests to the US as we possibly can.”
Despite the approval for use in the US,the tests will not be rolled out in Australia,which has a different regulatory framework.