On Mar. 5, 2021, Cue Health announced it had received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over the counter sale of its fast, accurate, COVID-19 test, making it the nationﾒs first molecular diagnostic test available to consumers without a prescription.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use (Cue OTC Test) uses a lower nasal swab and delivers results in about 20 minutes to the userﾒs mobile smart device. The Cue OTC Test was authorized for use by symptomatic and asymptomatic individuals, adults and children ages 2 and older with adult assistance.