FDA has authorized the Ellume COVID-19 home test for non-prescription use in adults and children 2 years and up, whether they are symptomatic or not. The first-of-its-kind test has been heralded as a genuine breakthrough in COVID-19 testing and comes at a pivotal time in America's ongoing battle against the pandemic as the country is expected to have two authorized vaccines by the end of the week.

Ellume, a digital diagnostics company headquartered in Queensland, Australia with U.S. operations in Valencia, CA, says the 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, schools, 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, Sean Parsons, MD. “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.”

The test is based on core digital diagnostics technology that has been developed over ten years. The self-test works in conjunction with a free software application downloaded on the user’s smartphone, which provides easy-to-read, step-by-step instructions including a how-to 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.

"This is a genuine breakthrough in COVID-19 testing," said Lamar Alexander (R-TN), chairman of the U.S. Senate health committee. "A low-cost, reliable test that can be bought over-the-counter without a prescription and taken at home in 15 minutes. This is the result of the extraordinary efforts of the National Institutes of Health’s ‘Shark Tank,’ or RADx initiative, which has produced 22 new ways to create tens of millions of diagnostic tests in the last eight months.”

Alexander and Roy Blunt (R-MO), chairman of the Senate health appropriations committee, led an effort in April to pass funding for the competitive "Shark Tank" at NIH so it could work in coordination with the Biomedical Advanced Research and Development Authority and the private sector to fast track new technologies designed to produce tens of millions of tests.

How the Ellume COVID-19 testing system works

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. Using the app, the consumer 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 testing system can provide real-time reporting of test results to health authorities, employers, and educators, for efficient COVID-19 mapping.

Clinical performance

In data submitted to 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. Ellume said 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.

What is the core technology of this COVID-19 testing system?

The test’s core technology combines ultra-sensitive optics, electronics, and software to leverage digital immunoassay technology with next-generation multi-quantum dot fluorescence technology. Ellume said its patented detection method is designed to detect 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.

Manufacturing scale-up

Thanks to a $30 million grant from the NIH RADx initiative, Ellume has been able to fast-track the development of its range of COVID-19 testing systems. In order to meet anticipated demand, Ellume said it 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 United States. Production is already underway and Ellume will be shipping more than 100,000 tests a day beginning in January. Ellume plans to manufacture and deliver 20 million Ellume COVID-19 home tests to the United States within the first half of 2021.