FDA authorizes Ellume COVID-19 Home Test as First Over-the-Counter Fully At-Home Diagnostic Test
Digital diagnostics company Ellume today announced its rapid, at-home COVID-19 antigen test has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The test will be available for non-prescription home use for the detection of active COVID-19 in individuals with or without symptoms, and in adults and children aged 2 years and above. The Ellume COVID-19 Home Test is the first of its kind to be granted an EUA and provides an essential new tool to help combat the COVID-19 pandemic.
The Ellume self-test will help reduce the spread of COVID-19 through rapid self-detection, providing users with real-time results at home, enabling self-isolation and patient education on escalation of medical care. Alongside the recently authorized COVID-19 vaccine, Ellume’s self-test will provide critical support to the United States as it transitions out of the pandemic, delivering rapid, accurate test results and facilitating a safe return to workplaces, educational institutions, and travel.
“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” 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 U.S. to respond to the pandemic in its most urgent stage.”
With core technology developed over ten years, Ellume’s COVID-19 Home Test combines ground-breaking technology with world-class usability to offer best-in-class at-home digital diagnostics. 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, the test result is displayed on the user’s smartphone in 15 minutes or less.
In data submitted to the FDA from an independently run, simulated home-setting clinical study of 198 subjects ranging in age from 2 years to 82 years, the Ellume COVID-19 Home Test demonstrated 96% accuracy, with an overall sensitivity of 95% (positive percent agreement) and specificity of 97% (negative percent agreement) when compared to an emergency use-authorized RT-PCR laboratory test.
In individuals presenting with COVID-19 symptoms, the Ellume COVID-19 Home Test demonstrated a sensitivity of 96% and specificity of 100%, and in asymptomatic individuals, the test demonstrated a sensitivity of 91% and specificity of 96%.
This level of accuracy across both symptomatic and asymptomatic individuals is crucial in mitigating the spread of an infectious disease like COVID-19, which can be spread unknowingly. The clinical study cohort was designed to be widely representative of ages and genders and spanned five testing locations 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 at-home COVID-19 antigen test demonstrated premium performance.
Supercharged fluorescent immunochromatography using a quantum-dot based fluorescent particle
The Ellume COVID-19 Home Test’s core technology combines ultra-sensitive optics, electronics and proprietary software to leverage best-in-class digital immunoassay technology with next-generation multi-quantum dot fluorescence technology.
The patented detection method detects minute fluorescence signals using unique fluorescent nanoparticles and a sophisticated reader system to achieve accurate results from a clinical sample, overcoming the sensitivity limitations of typical lateral flow technology. The key elements of Ellume’s digital technology reduce the probability of false results, create new pathways to treatment, and optimize secure public health reporting. These unique features are critical to the approval, success and adoption of self-administered home testing.
How it works
Safe, accurate and rapid self-test
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.
Ellume has been able to fast-track the development of its range of COVID-19 diagnostic tests with the support of a $30 million WP-2 grant from the U.S. National Institutes of Health (NIH)’s Rapid Acceleration of Diagnostics (RADx) initiative.
In order to meet anticipated demand, Ellume has expanded its manufacturing facility in Brisbane, Australia, the largest of its kind in the Southern Hemisphere, and is rapidly expanding its manufacturing efforts and supply chain within the U.S. Production has already commenced and Ellume will be shipping over 100,000 tests per day from next month. Ellume plans to manufacture and deliver 20 million Ellume COVID-19 Home Tests to the U.S. within the first half of 2021.
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This project has been funded in part by the NIH RADx initiative with U.S. 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 No. 75N92020C00034. Ellume acknowledges the great assistance of the NIH in making practical Covid19 rapid testing an effective reality.
The Ellume COVID-19 Home Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for non-prescription home use. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.