The Ellume COVID-19 home test app
The Ellume COVID-19 Home Test connects directly to users’ smartphones and provides step-by-step instructions and display of test results.
The Ellume COVID-19 home test in use
The Ellume COVID-19 Home Test includes instructions for use, a sterile pediatric nasal swab with adapter, a dropper, processing fluid and analyzer. The Bluetooth® app guides users through step-by-step instructions on how to perform the test and receive a result.
The Ellume COVID-19 Home Test box
The Ellume COVID-19 home test will be available over the counter and validated for use with and without symptoms.
- FDA Grants Emergency Use Permission for Ellume COVID-19 Home Test Over-the-Counter Home Test in Symptomatic and Asymptomatic Individuals
- The test demonstrated 96% accuracy in a US multi-site clinical study in both adults and children 2 years of age and older
- Ellume is ramping up production and production is on track for more than 100,000 tests per day in January 2021
VALENCIA, Calif. And BRISBANE, Australia, December 15, 2020 (GLOBE NEWSWIRE) – Digital Diagnostic Company Ellume announced today that its rapid home COVID-19 antigen test has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The test will be available for home use without a prescription for the detection of active COVID-19 in subjects with or without symptoms, and in adults and children 2 years of age and older. The Ellume COVID-19 Home Test is the first of its kind to receive an EUA and provides an essential new tool to combat the COVID-19 pandemic.
The Ellume Self Test helps reduce the spread of COVID-19 through rapid self-detection, giving users real-time results at home, enabling self-isolation and patient education on escalation of medical care. In addition to the newly approved COVID-19 vaccine, Ellume’s self-testing will provide critical support to the United States in its transition from the pandemic, provide fast, accurate test results and enable safe return to workplaces, educational institutions and travel.
“With the number of COVID-19 cases hitting record highs, the world needs access to fast, affordable, and easy-to-use home tests,Said Ellume founder and CEO, Dr. Sean Parsons. “Ellume’s COVID-19 home test delivers this important first line of defense – it can be widely available without the need for a prescription, enabling the US to respond to the pandemic in its most urgent phase. “
With core technology developed over a decade, Ellume’s COVID-19 Home Test combines breakthrough technology with world-class usability to provide the best in home digital diagnostics. The self-test works in conjunction with a free software application (app) that is downloaded on the user’s smartphone and provides easy-to-read, step-by-step instructions, including a video on how to use it. All analyzes are performed by the electronic analyzer of the test and using Bluetooth® connectivity, the test result will be displayed on the user’s smartphone in 15 minutes or less.
Clinical Performance
In data provided to the FDA from an independently conducted, simulated home clinical trial with 198 subjects aged 2 years to 82 years, the Ellume COVID-19 home test demonstrated 96% accuracy with overall sensitivity of 95% (positive percent agreement) and specificity of 97% (negative percent agreement) compared to an emergency authorized RT-PCR laboratory test.
In subjects with COVID-19 symptoms, the Ellume COVID-19 home test showed a sensitivity of 96% and a specificity of 100%, and in asymptomatic subjects, the test showed a sensitivity of 91% and a specificity of 96%.
This level of accuracy in both symptomatic and asymptomatic individuals is crucial to prevent the spread of an infectious disease such as COVID-19, which can be spread unknowingly. The clinical trial cohort was designed to be broadly representative of ages and genders and included five trial sites in California, Texas, Alabama, Maryland and Louisiana.
A further independent analytical evaluation was conducted by Emory University, Georgia Institute of Technology and Children’s Healthcare of Atlanta for the NIH RADx Tech program and determined that of the rapid antigen tests evaluated by the RADx Testing Core at the time, Ellume’s COVID home -19 antigen test showed first-class performance.
Core technology
Supercharged fluorescent immunochromatography using a quantum dot based fluorescent particle
The core technology of the Ellume COVID-19 Home Test combines ultra-sensitive optics, electronics and proprietary software to leverage best-in-class digital immunoassay technology with the next generation of multi-quantum dot fluorescence technology.
The patented detection method detects tiny fluorescence signals using unique fluorescent nanoparticles and an advanced reader system to obtain accurate results from a clinical sample, overcoming the sensitivity limitations of typical lateral flow technology. Key elements of Ellume’s digital technology reduce false results, create new pathways to treatment and optimize safe public health reporting. These unique features are critical to the approval, success and acceptance of self-administered home tests.
How it works
Safe, accurate and fast self-test
The test includes a sterile nasal swab, a dropper, processing solution 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 nasal swab in the center of the nasal concha. The sample is analyzed and the results are automatically sent 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.
Production upscaling
Ellume has been able to accelerate development of its range of COVID-19 diagnostic tests with the support of a $ 30 million WP-2 grant from the Rapid Acceleration of Diagnostics (RADx) initiative of the U.S. National Institutes of Health (NIH ).
To meet anticipated demand, Ellume has expanded its production facility in Brisbane, Australia, the largest of its kind in the Southern Hemisphere, and is rapidly expanding its manufacturing efforts and supply chain in the US. Production has already started and Ellume will start shipping more than 100,000 tests per day from next month. Ellume plans to manufacture and ship 20 million Ellume COVID-19 Home Tests to the US by the first half of 2021.
About Ellume
Ellume is at the forefront of accurate, rapid and accessible testing that is an integral part of the current COVID-19 response and will help prepare the world for the next contagious pandemic. Ellume is a digital diagnostics company that develops, manufactures and commercializes high-quality, connected products for healthcare professionals and consumers. Ellume’s main focus is on the detection of common infectious diseases affecting the world’s population in all diagnostic environments; at home, at the point of care and in the laboratory. Ellume’s range of products differs from conventional diagnostics in performance, digital connectivity, usability and simplicity. Its new detection technology is powered by unique quantum dot nanoparticles and integrates optics, electronics, biological technology and software in an intuitive and powerful digital platform. Ellume has a global consumer health partnership with GlaxoSmithKline, a global partnership with COVID-19 and latent tuberculosis with QIAGEN, and a range of professional products under the ellume lab brand. Ellume is committed to developing high-quality digital diagnostics that the world can rely on in a health crisis.
More information can be found at ellumehealth.com.
This project was funded in part by the NIH RADx Initiative with US federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Biomedical Advanced Research and Development Authority, Department of Health and Human Services, under contract number 75N92020C00034. Ellume recognizes the NIH’s great help in making practical Covid19 rapid tests effective.
The Ellume COVID-19 home test has not been approved or cleared by the FDA. It is approved by the FDA under an emergency home use permit without a prescription. The test is only approved for the detection of proteins from SARS-CoV-2, not for other viruses or pathogens, and is only allowed for the duration of the declaration that there are circumstances permitting emergency use of in vitro diagnostic tests justify. for detection and / or diagnosis of COVID-19 under Section 564 (b) (1) of the Act, 21 USC § 360bbb-3 (b) (1), unless the authorization is terminated or revoked earlier.
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