But so far, there are no plans to approve the tests for use in Australia.
"It has been a lot of work from many hundreds of people over a decade, and a terrific team effort to get to this pointâ¦it is very rewarding," Ellume founder and CEO Dr Sean Parsons told Today.
The company had been working on developing a test for the flu when they changed tact to deal with the coronavirus, he said.
"We were able to take that core technology and spin that into a COVID test pretty quickly. The technology was well advanced, and we were able to get the first at-home test, non-prescription, through the FDA, with an emergency use authorisation.