The Department of Defense (DOD), with collaboration from the Department of Health and Human Services (HHS), awarded a $231.8 million contract to Ellume USA to help fund domestic production of the Ellume COVID-19 Home Test, according to a press release.
With the funding, Ellume plans to open its first U.S. manufacturing facility, increasing Ellume’s global production capacity by more than 500,000 tests per day once completed. The company also will deliver 8.5 million COVID-19 at-home tests to the United States government, which will distribute them throughout the country.
This U.S.-based manufacturing capacity builds on Ellume’s existing Australian-based production capacity, which is on-track to procure approximately 200,000 tests per day this quarter. Under the agreement with the United States, Ellume plans to deliver 100,000 tests per month from the Australian manufacturing facility until the U.S. facility is built. At full capacity, the U.S facility will be able to produce up to 19 million tests per month, according to a company news release.
Ellume’s COVID-19 Home Test received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the detection of COVID-19 in individuals with or without symptoms. The test can be purchased without a prescription and used in an at-home setting, without assistance from a physician or health care provider. The test can be performed in approximately 15 minutes from a nasal swab specimen with results reported via a smartphone app.
Development of Ellume’s COVID-19 Home Test was supported by the National Institutes of Health (NIH)’s Rapid Acceleration of Diagnostics (RADx) initiative program beginning in May 2020.
