FDA Grants EUA to First COVID-19 Test for Non-Prescription Home Use in Symptomatic and Asymptomatic Individuals

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to the a rapid, at-home test for non-prescription home use for the detection of active COVID-19 in individuals with or without symptoms, and in adults and children aged two years and above.

The Ellume COVID-19 Home Test from Ellume (Brisbane, QLD, Australia) 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 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.

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.

In data submitted to the FDA from an independently run, simulated home-setting clinical study of 198 subjects ranging in age from two 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%.

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 as the world 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 US to respond to the pandemic in its most urgent stage.”

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