Ellume’s tests won US FDA emergency approval in December and the US government will procure 8.5 million of the over-the-counter kits which cost about $40.
The funding will help Ellume to ramp up their production capacity by 640,000 tests per day by December 2021, the US Department of Defence said on Monday.
The self-performed tests can be sold over the counter in the US and they give results within 15 minutes.
The US Centre for Disease Control said about 50 per cent of COVID-19 cases were transmitted asymptomatically so Ellume’s test will play a crucial role as the only diagnostic tool authorised for non-prescription use as a screening tool in the United States.
Ellume chief executive Dr Sean Parsons said the company’s focus was to enable the US to minimise community transmission and reopen as quickly as possible.
“We are prioritising our partnership with the US government to mobilize tests quickly and in the most impactful way. We will fulfill the order for these tests at the same time as we ramp up the output across our production facilities, creating more possibilities for retail and private institution use in the future,” Parsons said.
The agreement includes funding to support the establishment of Ellume’s US-based manufacturing facility and the delivery of 8.5 million COVID-19 home tests that will be distributed across the US. This US-based manufacturing capacity builds upon Ellume’s existing Australian production capacity which is on-track to procure about 200,000 tests a day this quarter.
Under the agreement, Ellume will be delivering 100,000 tests a month from the Australian manufacturing facility until the American facility is built whch should be able to produce up to 19 million tests a month.
Parsons said the Brisbane company had a “running start” at getting US approval as they had been working on a home flu test for “the best part of a decade”.
“When COVID arose, we were able to take that core technology and spin that into a COVID test pretty quickly,” Parsons told Nine’s Today program.
“It is a single-use kit … You take a swab of your nose, apply it to the test and you have a result in 15 minutes.”
The tests show roughly 95 per cent accuracy, White House COVID-19 senior advisor Andy Slavitt said during a press conference on Monday.
The test is not currently used in Australia, but Ellume has been in talks with the federal government.
“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,” Parsons said.
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