09 Feb 2021

Brisbane company's home COVID testing kits approved for use in United States in landmark deal

A Brisbane-based company has signed a landmark $300 million deal with the United States government to roll out an at-home coronavirus testing kit.

Ellume Health has developed the first non-prescription over-the-counter test approved in the US.

The kits, which have been in development for a decade, have more than a 95 per cent accuracy in detecting COVID-19.

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 point…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.

"The accuracy is 96 per cent over all. We have an authorisation for testing people with symptoms and without symptoms, and we are the only at-home test which is authorised for that use.

"We need to be able to pick up the asymptomatic people (as well as those with symptoms) to help reduce the spread of COVID."

The Biden administration said distribution of the at-home kits would increase across the country in the coming months.

"Ellume has been ramping up manufacturing and will ship 100,000 test kits per month to the US from February through July," Andy Slavitt, senior White House adviser for COVID-19 response, said.

Under the deal, Ellume will "be able to scale their production to manufacture more than 19 million test kits per month by the end of this year, 8.5 million of which are guaranteed to the US government," Mr Slavitt said.

The test provides a result in 15 minutes.

Th single-use antigen test, sold over the counter, can be done at home using a nasal swab, dropper and processing fluid. The test uses an analyser that connects with a software app on your smartphone to help you perform the test and then interpret your results all from home, similar to at-home pregnancy tests.

But so far there are no plans to approve the tests for use in Australia despite Dr Parsons' company having talks with the Federal Government.

"The needs of Australia are a bit different at the moment to the needs of America," Dr Parsons said.

"Australia has done a good job in getting on top of that spread, and the kinds of tests that we need here in Australia are different to the US for the time being.

"We have had some discussions with the Federal Government, but nowhere near the kind of engagement we have had in the US. We hope that will change and evolve over time.

"We think we have proven that we have world-class science that can help countries respond and we would certainly welcome a broad conversation with the Australian Government on how we can help Australia recover from the pandemic."

SOURCE: https://www.9news.com.au/national/united-states-approves-at-home-coronavirus-testing-kit-by-brisbane-company-ellume/58f4b1fe-0083-4fa9-9baf-f997e4579398

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