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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'
People queue to be tested for COVID-19 in Times Square, as the Omicron coronavirus variant continues to spread in Manhattan, New York City, U.S., on Dec. 20, 2021. (REUTERS/Andrew Kelly)
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"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.
