PERTH, Australia –Digital diagnostics company Ellume Ltd. announced a US$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 U.S. production of its COVID-19 home tests.

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.

This U.S.-based manufacturing capacity builds upon Ellume’s existing Australian production capacity, which is on-track to procure roughly 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.

The investment will support the establishment of Brisbane, Australia-based Ellume’s first U.S. manufacturing facility, increasing Ellume’s global production capacity by more than 500,000 tests per day once completed. The Ellume COVID-19 home test was the first over-the-counter self-test authorized by the U.S. FDA.

The FDA granted an emergency use authorization (EUA) to Ellume for its COVID-19 home test in December 2020. The rapid lateral-flow test for antigen detection can be obtained without prescription and will return results to the at-home user in 20 minutes.

The Ellume test is the first test that can be used entirely at home without a prescription, although the agency advised that the sensitivity and specificity of the Ellume test do not match the performance of molecular tests performed with polymerase chain reaction testing systems.

“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 CEO Sean Parsons.

Ellume’s rapid self-test for COVID-19 detection was cleared 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 U.S.

Studies of the Ellume test demonstrated a sensitivity of 96% and specificity of 100% of in symptomatic individuals, while performance in asymptomatic individuals was 91% sensitivity and 96% specificity. The test is used with an app downloaded to a smartphone, which provides instructions for use and “reports the results as appropriate to public health authorities,” the FDA said.

The test is designed to detect the SARS-CoV-2 virus from mid-turbinate nasal swabs drawn from any individual aged at least 2 years.

The test kit includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer for use with an app on the user’s smartphone. Using 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 then be shared with health care professionals.

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.

The EUA was based on a simulated home-setting clinical study of nearly 200 subjects aged 2 to 82 years. Enrollment in the study spanned five U.S. states, including Texas and California, and the results of the study were confirmed by scientists at Emory University in Atlanta.

Ellume is a participant in the National Institutes of Health’s (NIH) 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.

Ellume’s key focus is on detecting common infectious diseases that affect the global population across all diagnostic settings; at-home, point-of-care and in-laboratory.

Sean Parsons, the founder of the private company, said he was working as a physician in an emergency department in 2009 when patients were being admitted with flu-like symptoms that turned out to be the swine flu. At the time, laboratory tests took several days to return results, and patients sometimes received inappropriate antiviral drugs because there weren’t rapid flu tests to diagnose patients quickly.

“It was then that I realized there was a clear need for a faster, simpler and more accurate way to diagnose influenza and other infectious diseases,” Parsons said.

The underlying technology consists of ultra-sensitive optics and proprietary software combined with multi-quantum dot fluorescence technology.

Ellume received financial support from the Queensland State government as well, and solicited the support of Bosch Australia Manufacturing Solutions to expand capacity at its Brisbane plant.