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# Cue Health Files De Novo App for RSV Test
- URL: https://www.fdaweb.com/cue-health-files-de-novo-app-for-rsv-test/
- Published: 2023-05-09T12:00:00.000Z
- Updated: 2026-09-14T18:30:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154406

Cue Health has filed a de novo submission seeking permission to market its Cue RSV Molecular Test for at-home and point-of-care use for detecting respiratory syncytial virus. If granted, the test would be the first of its kind for use in people of all ages, the company says. The test cartridge uses a lower nasal swab and is compatible with the Cue Reader, which provides test results digitally via Bluetooth to a mobile device in about 25 minutes, it says.

Cue says its Covid-19 test was the first molecular diagnostic test to obtain an emergency use authorization for at-home and over-the-counter use without a prescription. That test is currently under de novo review with the agency for a full marketing authorization, it adds.