On Feb. 1, 2021, the Department of Defense (DOD), in coordination with the Department of Health and Human Services, awarded $231.8 million to Ellume USA LLC to onshore production capacity of the Ellume COVID-19 Home Test for the United States.
Back in mid December 2020, the US FDA (Food and Drug Administration) granted Emergency Use Authorization for Ellume COVID-19 Home Test for non-prescription home use in symptomatic and asymptomatic individuals. Ellume says its test "demonstrated 96% accuracy in a multi-site US clinical study of both adults and children 2 years and above", with the company "ramping up manufacture, with production on track for over 100,000 tests per day in January 2021."
We're told "this industrial base expansion effort will allow Ellume USA LLC to increase production capacity of the Ellume COVID-19 Home Test in the United States by 640,000 tests per day by December 2021, to support domestic COVID-19 testing."
"The expansion includes the procurement of 8.5 million tests that will be distributed across the U.S. in accordance with the National Strategy for the COVID-19 Response and Pandemic Preparedness policy established January 21, 2021.
"Ellume’s COVID-19 Home Test is the first fully at-home diagnostic test to receive a Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the detection of COVID-19 in individuals with or without symptoms.
"The test will be able to be purchased without a prescription and utilised 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," with the test reported to cost approx $40.
"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.
"The DOD’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) led this effort, in coordination with the DOD’s Defense Assisted Acquisition (DA2) Cell. This effort was funded through the Health Care Enhancement Act (HCEA), to support domestic production of critical medical resources."
According to an ABC Australia news report, White House senior advisor Andy Slavitt is quoted stating 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," and noted that "The ability to quickly test, to contact trace and quarantine is a linchpin of our national strategy and will be a vital part of containing the virus and stopping community spread."