2nd February 2021 Product update: rapidvirology staff writer
Biden Invests in Rapid Self-Tests for Americans
Ellume has 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.
The self-test works in conjunction with a free software application (app) downloaded on the user’s smartphone, which provides easy-to-read, step-by-step instructions including a how-to-use video.
All analysis is performed by the test’s electronic analyzer and using Bluetooth® connectivity, and the test result is displayed on the user’s smartphone in 15 minutes or less.
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 on 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 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.
How it works
The test includes a sterile Nasal Swab, a Dropper, Processing Fluid, and a Bluetooth® connected Analyzer for use with an app on the user’s smartphone. Utilizing the dedicated app, the user follows step-by-step video instructions to perform the test, including a self-collected mid-turbinate nasal swab.
The sample is analyzed, and results are automatically transmitted to the user’s smartphone via Bluetooth® in 15 minutes or less. Results can be shared with healthcare professionals to enable optimal therapy.
Through a secure cloud connection, Ellume’s COVID-19 Home Test can provide real-time reporting of test results to health authorities, employers, and educators, for efficient COVID-19 mapping.
Date Published: 2nd February 2021
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Note: This content has been edited by a rapidvirology.com staff writer for style and content.
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