FDA Authorizes Cue Health’s COVID-19 Test for At-Home and Over The Counter Use
Cue is the First to Offer Molecular Diagnostic Testing to Consumers in the U.S. Without a Prescription
- FDA grants Emergency Use Authorization for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use for symptomatic and asymptomatic individuals, ages 2 and older
- Prospective studies comparing the Cue OTC Test to a highly sensitive FDA-EUA authorized PCR laboratory-based test found 97.4% agreement for positive cases and 99.1% agreement for negative cases
- Cue provides a fast, automated process from sample collection to results in about 20 minutes using a lower nasal swab
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