- FDA Authorizes Ellume COVID-19 Home Test as First Over-the-Counter Fully At-Home Diagnostic Test.
- Ellume’s test looks for viral proteins shed by COVID-19, which is different from the gold standard tests that look for the genetic material of the virus.
- Clinical Performance
- Core Technology
- How it works
Over-the-counter home test for COVID-19 gets US green light
MATTHEW PERRONE,
Dec. 15, 2020 | Updated: Dec. 15, 2020 11:59 a.m.
AP Health Writer
WASHINGTON (AP) — The first home test for COVID-19 that doesn't require a prescription will soon be on U.S. store shelves.
U.S. regulators Tuesday authorized the rapid coronavirus test, which can be done entirely at home. The announcement by the Food and Drug Administration represents another important — though incremental — step in efforts to expand testing options.
Regulators granted emergency use for a similar home test last month, but that one needs a doctor’s prescription.
The agency's action Tuesday allows sales in places like drugstores "where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen Hahn, in a statement.
Initial supplies of the over-the-counter test will be limited. Australian manufacturer Ellume said it expects to produce 3 million tests next month before ramping up production over the first half of 2021.
A company spokesperson said the test will be priced around $30 and be available at pharmacies and for purchase online.
The kit includes a nasal swab, a chemical solution and a testing strip. The test connects digitally to a smart phone app that displays the results and then helps interpret the results. Users can also connect with a health professional via the app.
For months, health experts have stressed the need for fast, widespread home testing so that people can screen themselves and avoid contact with others if they have an infection. But the vast majority of tests still require a nasal swab performed by a health processional that must be processed at high-tech laboratories. That typically means waiting days for the results. About 25 tests allow people to collect their own sample at home— a nasal swab or saliva — but then that's shipped to a lab.
Ellume’s test looks for viral proteins shed by COVID-19, which is different from the gold standard tests that look for the genetic material of the virus.
Like other tests that scan for proteins, FDA officials noted that Ellume’s test can deliver a small percentage of false positive and false negative results. People who get a negative result but have coronavirus symptoms should follow up with a health professional, the agency said.
Currently the U.S. is testing nearly 2 million people daily. Most health experts agree the country needs to be testing many times more and researchers at Harvard have pushed for cheap, paper home tests.
Still, Dr. Michael Mina of Harvard called the new test “a great addition," to existing options, though he cautioned that its price could limit access.
“This is a milestone, with reservations,” Mina said in an email. “I just hope it doesn’t drive more of a wedge between haves and have nots."
For people with insurance, federal law requires that plans cover the cost of COVID-19 testing.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
https://hosted.ap.org/journalrecord/article/ac070f4d42d9d7eacc486c9bed4ccaa0/fda-allows-use-over-counter-home-test-covid-19
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COVID-19 HOME TEST
SAFE, ACCURATE AND RAPID SELF-TEST
The Ellume COVID-19 Home Test is an over-the-counter, rapid self-test which detects SARS-CoV-2 antigen. The test is suitable for ages 2+ years for symptomatic and asymptomatic use. It enables individuals to test for COVID-19 infection in 15 minutes, anywhere.
The self-test offers a substantial benefit to COVID-19 hotspots, by enabling early detection so users can self-isolate and seek medical care to limit the spread of COVID-19.
HOW IT WORKS
Utilizing the dedicated app, the user follows step-by-step instructions to perform the test including a self-collected mid-turbinate swab. The sample is analyzed and results are automatically transmitted to the user’s smartphone via Bluetooth®. Results can be shared with healthcare professionals to enable optimal therapy.
Through a secure cloud connection, the Ellume COVID-19 Home Test provides real time reporting of test results and critical data to health authorities, employers and educators, for efficient COVID-19 mapping.
KEY FEATURES
- Time to result: 15 minutes
- Highly accurate
- Suitable for asymptomatic & symptomatic testing
- Suitable for ages 2+ years
- Animated, on-screen instructions
- Results displayed automatically on-screen
- User-friendly mid-turbinate nasal swab with child adapter
- Real-time reporting through secure, HIPAA compliant cloud connection
https://www.ellumehealth.com/products/consumer-products/covid-home-test
https://www.ellumehealth.com/products/consumer-products/covid-home-test
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Dr Sean Parsons
— Graviola Finland (@GraviolaDOTfi) December 15, 2020
Founder & CEO and Managing Director of Ellume, a digital diagnostics company that develops, manufactures and commercializes high-performance, connected products for health professionals and consumershttps://t.co/gga7cBBL3K pic.twitter.com/yUz0LqYyej
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With #RADx support, first #COVID19 test designed for use at home without prescription is now authorized for emergency use by FDA #NIBIBfunded @EllumeHealth @NIH @BARDA https://t.co/lTDwYyTb9k pic.twitter.com/AVw8enwP0m
— NIBIB (@NIBIBgov) December 15, 2020
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FDA Authorizes Ellume COVID-19 Home Test as First Over-the-Counter Fully At-Home Diagnostic Test
Proven performance in adults and children, with and without symptoms
- FDA grants Emergency Use Authorization for Ellume COVID-19 Home Test for non-prescription home use in symptomatic and asymptomatic individuals
- The test demonstrated 96% accuracy in a multi-site US clinical study of both adults and children 2 years and above
- Ellume is ramping up manufacture, with production on track for over 100,000 tests per day in January 2021
-- 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.
Clinical Performance
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.
Core Technology
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.
Manufacturing Scale-Up
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.
| U.S. Media Inquiries | Australian Media Inquiries |
| LaunchSquad for Ellume E: ellume@launchsquad.com M: +1 570 417 3644 | Patrick Condren, Ellume E: Patrick.condren@ellumehealth.com M: +61 405 186 630 |
About Ellume
Ellume is at the forefront of accurate, rapid and accessible testing that is integral to today’s COVID-19 response and will help ensure the world is prepared for the next infectious disease pandemic. Ellume is a digital diagnostics company that develops, manufactures, and commercializes high-performance, connected products for healthcare professionals and consumers. Ellume’s key focus is on the detection of common infectious diseases which affect the global population across all diagnostic settings; at-home, point-of-care and in-laboratory. Ellume’s suite of products differ from conventional diagnostics through performance, digital connectivity, actionability and simplicity. Its novel detection technology is powered by unique quantum dot nanoparticles and integrates optics, electronics, biologics and software into an intuitive and high-performance digital platform. Ellume has a global consumer health partnership with GlaxoSmithKline, a global COVID-19 and latent TB partnership with QIAGEN, and a range of professional products under its ellume·lab brand. Ellume is committed to developing high-quality digital diagnostics that the world can rely on in a health crisis.
Further information can be found at ellumehealth.com.
This project has been 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 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.
Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/31ab89ab-d16d-4142-bf8d-7972c2dd19a5
https://www.globenewswire.com/NewsRoom/AttachmentNg/9ab4a3cd-7d22-41e0-a625-d75d4d8e1cd7
https://www.globenewswire.com/NewsRoom/AttachmentNg/2f84ba3f-fbce-42f5-b638-6bf3172216d7
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CORONAVIRUS: THE FACTS
* Last update: 20 August 2020 – https://www.who.int/emergencies/diseases/novel-coronavirus-2019
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