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December 16, 2020

US FDA grants EUA to Ellume’s at-home Covid-19 diagnostic test

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to digital diagnostics company Ellume’s at-home Covid-19 viral antigen test.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to digital diagnostics company Ellume’s at-home Covid-19 viral antigen test.

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Developed with $30m contract and technical support from the National Institutes of Health (NIH)’s Rapid Acceleration of Diagnostics (RADx) Initiative, the Ellume Covid-19 Home Test will be available without a prescription for use at home.

It can be used for detecting active Covid-19 in adults and children aged two years or above with or without symptoms.

Ellume founder and CEO Dr Sean Parsons said: “As Covid-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing.

“Ellume’s Covid-19 Home Test delivers this important first line of defence – it can be widely available without the need for a prescription, enabling the US to respond to the pandemic in its most urgent stage.”

For the test, the sample is collected using a mid-turbinate nasal swab.

The sample is then inserted into a single-use cartridge that delivers results in 15 minutes.

In addition, the at-home test analyser connects to the user’s smartphone via Bluetooth. It pairs with an app that gives step-by-step guidelines and displays results.

The test costs approximately $30. With it, users can share real-time results with healthcare specialists, employers, and schools.

The company expects to scale up manufacturing to supply millions of home tests a month next year.

In data submitted to the FDA from a clinical study on 198 subjects aged two to 82 years, the Ellume Covid-19 Home Test showed 96% accuracy with an overall sensitivity of 95% and specificity of 97% versus an emergency use-authorised RT-PCR laboratory test.

Furthermore, the test showed a sensitivity of 96% and specificity of 100% in people with symptoms and sensitivity of 91% and specificity of 96% in asymptomatic people.

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Navigate your business through the ‘new normal’

COVID-19 continues to dominate headlines the world over. It has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities.  Faced with an explosion of conflicting information on how to plan and implement successful recovery strategies, decision-makers are in dire need of a single, reliable source of intelligence.   GlobalData’s COVID-19 Executive Briefing gives you access to unparalleled data and insights to successfully navigate the uncertain road to recovery across the world’s largest industries. Understand every aspect of this disruptive theme by delving into: 
  •  COVID-19 infection update, with statistics on the spread, testing by country, as well as the latest data on vaccines and therapeutic developments 
  • Economic impact overview, covering stock market indices, GDP, unemployment rates, policy responses & GlobalData’s economic recovery scorecards 
  • Sector developments, with access to sector insight summaries, cross-sector indices and the leaders and laggards in each industry vertical 
Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today. 
by GlobalData
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