Ellume announces new agreement to scale-up US production

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The US government is investing in Australian digital diagnostics company Ellume with a $231.8 million agreement to accelerate domestic US production of its COVID-19 home tests.

The Ellume 'COVID-19 Home Test' is the first rapid self-test for COVID-19 detection authorised by the US FDA for both asymptomatic and symptomatic use without a prescription. 

The company's agreement is with the US Department of Defense (DOD), in coordination with the Department of Health and Human Services (HHS).

“Our focus is enabling the US to minimize community transmission and reopen as quickly as possible. The Ellume COVID-19 Home Test is the only authorized test of its kind and is an essential tool for the broader pandemic response in the US,” said Ellume founder and CEO, Dr Sean Parsons.

“We are prioritizing our partnership with the US government to mobilize tests quickly and in the most impactful way. We will fulfil 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.”

Ellume said the agreement includes funding to support the establishment of its US-based manufacturing facility and the delivery of 8.5 million COVID-19 home tests.

This US-based manufacturing capacity will build on Ellume’s existing Australian production capacity. The company said this existing capacity is on-track to procure approximately 200,000 tests per day this quarter. 

Under the agreement, Ellume will be delivering 100,000 tests per month from the Australian manufacturing facility until the US facility is built. At full capacity, the US facility will be able to produce up to 19 million tests per month.

Ellume is a participant in the National Institutes of Health (NIH)’s Rapid Acceleration of Diagnostics (RADx) initiative and this agreement further extends the engagement between Ellume and the US government in pandemic preparedness and response.