ROI For US With FDA's Emergency Use Approval Of Cue Health's OTC At-Home COVID-19 Test

08 Mar 2021

After federal agencies invested almost $500m to ensure Cue Health could scale up production, FDA announces the self-administered test will be available OTC. It's the agency's first emergency use authorization for an at-home molecular diagnostic test available nonprescription.

Cue Health's COVID-19 OTC molecular test has been approved at home. — Cue Health’s OTC at-home molecular nucleic acid amplification test includes single-use COVID-19 test cartridge and nasal swab, a cartridge reader and a mobile app.

The US Food and Drug Administration granted its first emergency use authorization for an OTC at-home molecular diagnostic test to Cue Health Inc. after investing $481m in the San Diego firm in 2020.

On 5 March, the FDA said it gave marketing authorization to Cue Health’s at-home molecular nucleic acid amplification test (NAAT)...