Digital diagnostic solutions developer and Life Sciences Queensland member, Ellume, is making waves on the world stage with the development and approval of its rapid, at-home COVID-19 antigen test, which enables individuals to detect the presence of the SARS-CoV-2 antigen in just 15 minutes, from the comfort of their own home.
In a bid to speed up the global pandemic recovery process, Ellume was granted Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) in December 2020 and in February 2021, announced a ground-breaking $231.8 million agreement with the U.S. Department of Defense (DOD), to accelerate domestic U.S. production of its at-home COVID-19 tests. The DOD funding supports the establishment of a U.S.-based manufacturing facility and the delivery of 8.5 million COVID-19 home tests to be distributed across the U.S.
The Ellume COVID-19 Home Test, suitable for those aged two (2) years and over, is the first home test to be approved for use in the United States that does not require a prescription and is authorised to test individuals with and without symptoms.
Ellume also recently announced the first retail availability of the Ellume COVID-19 Home Test at select CVS Pharmacies, America’s leading retail pharmacy, and a leader in COVID-19 testing, which remains a critical component of the nation’s pandemic response.
Based on Ellume’s core technology combining ultra-sensitive optics, electronics and proprietary software to leverage best-in-class digital immunoassay technology with next-generation multi-quantum dot fluorescence technology, the test demonstrated overall sensitivity of 95% and specificity of 97% in an independent home-use clinical study of 198 subjects aged between 2 and 82 years — demonstrating performance equivalent to or better than the rapid immunoassay tests currently used by doctors at the point-of-care.
Ellume Founder, CEO and Managing Director, Dr Sean Parsons, said the self-test offers a substantial benefit to high-density and heavily infected regions across the globe including the United States, by enabling early detection of the virus without the need to travel to busy testing clinics and risk the spread of infection.
“Our focus is enabling the U.S. to minimize community transmission and reopen as quickly as possible, assisting people to stay home and self-test for infection,” he said.
“To meet high demand in the United States, we’ve expanded our manufacturing facility in Brisbane to enable the production of approximately 100,000 tests per day this quarter. At full capacity, the U.S facility will be able to produce up to 19 million tests per month, significantly expanding our total production capacity.”
From here, we’ll also have the capability to expand out to other high-risk continents like Europe to aid in the pandemic management and tracing efforts of millions more people,” Dr Parsons said.
Ellume’s COVID-19 Home Test includes a sterile nasal swab, dropper, processing fluid, and provides real time reporting of test results and critical data through a secure cloud connection to the user as well as health authorities, employers and educators for efficient COVID-19 mapping via a Bluetooth® connected analyser on a dedicated app.
LSQ Chief Executive Officer Clare Blain said Ellume’s work in the COVID-19 space is an extension of its work in innovative digital diagnostics over the last decade.
“Having supported Ellume as an LSQ member since 2012, we’ve had the pleasure of witnessing the company’s breakthroughs in its core technology to enhance and revolutionise the testing processes for influenzas A and B, tuberculosis, and now SARS-CoV-2,” she said.
“Ellume’s agility in adapting its core technology to cater to the pandemic is a testament to the state’s capability in advanced bioscience and medical manufacture, and we’re excited to see this new technology utilised in markets across the globe to aid in pandemic recovery.”
To ensure the Ellume COVID-19 Home Test is made available to as many people as possible, the company is pursuing a multi-faceted rollout strategy including retail commercialization and partnerships with government and private enterprise. Ellume’s at-home test is available over-the-counter in select pharmacies in the U.S., with more to follow.