- The contract includes the delivery of 8.5 million Ellume COVID-19 Home Tests to support the U.S. Government’s pandemic response
- The investment will support the establishment of Ellume’s first U.S. manufacturing facility, increasing Ellume’s global production capacity by 500,000+ tests per day once completed;
- The investment extends Ellume’s engagement with the U.S. government following the NIH RADx announcement last year;
- The Ellume COVID-19 Home Test is the first non-prescription over-the-counter self-test authorized by the U.S. Food and Drug Administration
Valencia, California and Brisbane, Australia – Digital diagnostics company Ellume today announced a $231.8 million agreement with the U.S. Department of Defense (DOD), in coordination with the Department of Health and Human Services (HHS), 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 authorized by the U.S. FDA for both asymptomatic and symptomatic use without a prescription. With the CDC reporting that at least 50% of COVID-19 cases are transmitted asymptomatically, Ellume’s test will play a crucial role as the only diagnostic tool authorized for non-prescription use as a screening tool in the United States.
“Our focus is enabling the U.S. 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 U.S.” said Ellume founder and CEO, Dr. Sean Parsons.
“We are prioritizing our partnership with the U.S. government to mobilize tests quickly and in the most impactful way. 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,” Dr Parsons said.
The agreement includes funding to support the establishment of Ellume’s U.S.-based manufacturing facility and the delivery of 8.5 million COVID-19 home tests that will be distributed across the U.S. in accordance with the National Strategy for the COVID-19 Response and Pandemic Preparedness plan.
This US-based manufacturing capacity builds upon Ellume’s existing Australian production capacity which 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 U.S. facility is built. At full capacity, the U.S 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 U.S. government in pandemic preparedness and response.
This contract is being led by the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in coordination with the DOD Defense Assisted Acquisition Cell (DA2) and funded through the Health Care Enhancement Act (HCEA) to enable and support domestic production of critical medical resources. Ellume continues to pursue a multi-faceted rollout strategy of its COVID-19 Home Test including retail commercialization and partnerships with other public and private institutions.