US FDA grants emergency authorisation to Ellume's COVID-19 test

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The US FDA has granted emergency use authorisation to a new rapid at-home COVID-19 antigen test developed by Australian digital diagnostic company Ellume.

The company said 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 emergency use authorisation and provides a new tool to help combat the COVID-19 pandemic.

The self-test provides 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,” 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.”

The self-test works in conjunction with a free software application (app) downloaded on the user’s smartphone. The app provides easy-to-read, step-by-step instructions including a how-to-use video. All analysis is performed by the test’s electronic analyser and using Bluetooth connectivity. The test result is displayed on the user's smartphone in 15 minutes or less.

Ellume said it submitted data to the FDA based on an independently run, simulated home-setting clinical study of 198 subjects ranging in age from 2 years to 82. It said its COVID-19 Home Test demonstrated 96 per cent accuracy, with an overall sensitivity of 95 per cent (positive per cent agreement) and specificity of 97 per cent (negative per cent 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 per cent and specificity of 100 per cent, and in asymptomatic individuals, the test demonstrated a sensitivity of 91 per cent and specificity of 96 per cent.

The test includes a sterile nasal swab, a dropper, processing fluid and a Bluetooth connected analyser for use with an app on the user’s smartphone. 

Ellume said it 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 US National Institutes of Health’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 US.

"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 US within the first half of 2021," said the company.