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US FDA approves Cue Health's at-home COVID test

The U.S. Food and Drug Administration has granted marketing authorization to Cue Health's at-home COVID-19 test, the first to undergo traditional premarket review

The U.S. Food and Drug Administration on Tuesday approved Cue Health's at-home COVID-19 test, the first coronavirus test to get marketing authorization using a traditional premarket review, the agency said.

The FDA said this was the first ever at-home test authorized using the traditional review process for any respiratory illness.

FDA SAFETY OFFICIAL RESIGNS OVER 'STRUCTURAL ISSUES'

"This is part of the FDA's broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing," FDA official Jeff Shuren said in a statement.

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