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Mar 27, 2023US FDA approves Cue Health's at
Apr 28, 2023June 6 (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Cue Health's (HLTH.O) at-home COVID-19 test, the first coronavirus test to get marketing authorization using a traditional premarket review, the agency said.
The FDA had granted emergency use authorization for the test in 2021 to make it available to consumers without a prescription.
The agency's approval for the test comes nearly a month after the U.S. ended the public health emergency status for COVID, which has caused more than 1.1 million deaths in the country.
This was the first ever at-home test authorized using the traditional review process for any respiratory illness, the health regulator added.
"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.
The test can detect all known COVID variants of concern, the company said.
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