U.S. Department of Defense, DOD Awards $231.8 Million Contract to Ellume USA LLC to Increase Domestic Production of COVID-19 Home Test (release 2488793, February 1, 2021)
Summary
On Feb. 1, 2021 the Department of Defense, in coordination with the Department of Health and Human Services, awarded $231.8 million to Ellume USA LLC to onshore production of the Ellume COVID-19 Home Test, according to this DOD release. The award is meant to raise Ellume's U.S. production capacity by 640,000 tests per day by December 2021 and includes the procurement of 8.5 million tests for distribution under the national COVID-19 strategy of January 21, 2021. The release describes the product as the first fully at-home diagnostic test to receive an FDA Emergency Use Authorization for detecting COVID-19 in people with or without symptoms, sold without a prescription and giving results in approximately 15 minutes via a smartphone app. The effort was led by JPEO-CBRND with the DOD's Defense Assisted Acquisition Cell and funded through the Health Care Enhancement Act.
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Full text
Release Immediate Release DOD Awards $231.8 Million Contract to Ellume USA LLC to Increase Domestic Production Capacity and Deliver COVID-19 Home Tests Feb. 1, 2021 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. 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 utilized 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. 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. coronavirus Science covid19vaccine Subscribe to Defense.gov Products Choose which Defense.gov products you want delivered to your inbox. Subscribe
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