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Apr 27, 2023(Reuters) – 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.
"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.
(Reporting by Raghav Mahobe in Bengaluru; Editing by Krishna Chandra Eluri)