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

Cue Health

06/06/2023 20:25

(Adds FDA official comment from statement in paragraphs 2-3)
       June 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 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)
 ((Raghav.Mahobe@thomsonreuters.com;))