Cue Health's Covid-19 Test Gets FDA Marketing Authorization

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 rose 12% Tuesday to close at 59 cents.

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

Corrections & Amplifications

This article was corrected at 7:53 p.m. ET to reflect that Cue Health shares rose 12% Tuesday to close at 59 cents. The original version incorrectly said the rise was in after-hours trading.

(END) Dow Jones Newswires

June 06, 2023 16:31 ET (20:31 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.