NEW YORK – The US Department of Defense said on Monday that in coordination with the US Department of Health, it has awarded Ellume USA $231.8 million to produce the Ellume COVID-19 Home Test.
The US Food and Drug Administration provided Emergency Use Authorization for the test in December, making it the first over-the-counter, at-home test for COVID-19 to receive US EUA. The lateral flow immunoassay is for use with both asymptomatic and symptomatic patients and uses a mid-turbinate nasal swab and an analyzer that connects with a smartphone app that provides instructions on using the test and interpreting results, which are delivered in around 20 minutes.
At the time it received the EUA, Australia-based Ellume, which has a location in Valencia, California, said that it would be able to produce around 100,000 tests per day in January. In a statement on Monday, DoD said that the "industrial base expansion effort" facilitated by the award will increase production of the test in the US to 640,000 tests per day in the US by December 2021.
The US will procure 8.5 million of the test to distribute throughout the country, DoD said.
"We are prioritizing our partnership with the U.S. government to mobilize tests quickly and in the most impactful way," Ellume Founder and CEO Sean Parsons said in a statement. "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."
The company added that the funding will also support the establishment of Ellume's US-based manufacturing facility.
Development of the Ellume COVID-19 Home Test was supported by the National Institutes of Health through its Rapid Acceleration of Diagnostics (RADx) program.