Ellume’s COVID-19 Home Test shows 96% accuracy in multi-site US clinical study

• Ellume submits Emergency Use Authorization to the U.S. Food and Drug Administration for the Ellume COVID-19 home test
• Clinical study demonstrated overall sensitivity of 95% and specificity of 97%
• Clinically validated for use in symptomatic and asymptomatic users ages 2 years and above
• Independently run, simulated home-use clinical study of 198 subjects
• Ellume is ramping up manufacture, with production on-track for over 100,000 tests per day in January

VALENCIA, Calif. and BRISBANE, Australia, Dec. 09, 2020 (GLOBE NEWSWIRE) — Digital diagnostics company Ellume today announced its rapid, at-home COVID-19 antigen test has demonstrated 96% accuracy compared to an EUA molecular test in an independently-run, US clinical study in five (5) states. The Ellume COVID-19 home test was shown to be a safe and simple-to-use test for the detection of SARS-CoV-2 nucleocapsid antigen in users aged 2 years and above. The rapid self-test enables individuals to test for an active COVID-19 infection in 15 minutes or less.

Ellume has submitted its COVID-19 home test to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA).

In data submitted to the FDA from a simulated home-use clinical study of 198 subjects ranging in age from 2 years to 82 years, Ellume’s COVID-19 home test demonstrated 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%.

“Ellume set out in 2010 to create simple, rapid, accurate diagnostic tests for common infectious diseases. Today’s announcement is the culmination of a decade of work developing our core technology. The Ellume COVID-19 home test has demonstrated performance equivalent to or better than, the rapid immunoassay tests used by doctors at the point-of-care,” said Dr. Sean Parsons, Ellume founder and CEO.

Ellume’s COVID-19 home test works in conjunction with a free software application (app) downloaded on the user’s smartphone. The dedicated app provides step-by-step instructions including a how-to-use video and displays the result when the test is complete. All analysis is performed by the test’s electronic analyzer which connects to the user’s smartphone via Bluetooth^®.

Once authorized by the FDA, the test will be available over-the-counter for symptomatic and asymptomatic detection of SARS-CoV-2 antigen. Through early detection of infection, the test will reduce the spread of COVID-19 by empowering users with the information needed to reduce their risk of transmission. The test will also assist in allowing re-commencement of larger gatherings such as at sports, churches and concerts.

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 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 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 fast-tracked the development of its range of COVID-19 diagnostic tests with the support of a $30 million 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 in the U.S. Production has 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.

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.

About Rapid Acceleration of Diagnostics initiative
The National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. Accurate, fast, easy-to-use, and widely accessible testing is required before the nation can safely return to normal life. For further information please follow the FAQs link: https://www.nibib.nih.gov/radx-initiative-covid-19-testing/FAQ

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