Cue Health's Covid-19 Test Gets FDA Marketing Authorization
June 06 2023 - 4:46PM
Dow Jones News
By Sabela Ojea
Cue Health said Tuesday that its Covid-19 molecular test has
received a De Novo marketing authorization from the U.S. Food and
Drug Administration.
Shares climbed 12% to 59 cents in after-hours trading.
The healthcare technology company said its Covid-19 molecular
test, which can be used at home or at point-of-care settings,
delivers results in 20 minutes to connected mobile smart devices.
Covid-19 molecular tests detect genetic material called RNA from
the virus.
A De Novo request gives a marketing pathway to classify new
medical devices for which certain controls provide reasonable
assurances of safety and effectiveness.
Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix
(END) Dow Jones Newswires
June 06, 2023 16:31 ET (20:31 GMT)
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