Valencia-based medical technology manufacturer Ellume announced its rapid, at-home COVID-19 antigen test had been granted emergency use authorization from the U.S. Food and Drug Administration.
The test is set to 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 a new tool to help combat the COVID-19 pandemic.
The Ellume self-test is expected to 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.
“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” Ellume founder and CEO Dr. Sean Parsons said in a prepared statement. “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 10 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-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 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%, per the study results.
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.
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’s Rapid Acceleration of Diagnostics initiative.
Ellume plans to manufacture and deliver 20 million Ellume COVID-19 Home Tests to the U.S. within the first half of 2021.