First At-Home, Molecular OTC Diagnostic Test for COVID-19 Wins FDA Authorization

By MedTech Intelligence Staff

The test generates results within 20 minutes and can be used by adults and children over the age of two years old.

Today FDA gave the green light for the first over-the-counter and at-home diagnostic test for COVID-19. The emergency use authorization was granted to Cue Health, Inc The test consists of a single-use test cartridge, a single-use nasal swab, a cartridge reader and the Cue Health Mobile App, which can be downloaded onto a smart mobile device. Results are generated in about 20 minutes, and users must register with an account to use the device, which ensures that any applicable test results are reported to public health authorities.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use test conducts qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens collected with the sample wand. It is intended for use in adults or children two years of age and older, with or without COVID-19 symptoms.

The test correctly identified 96% of positive samples from symptomatic patients and correctly identified 100% of positive samples from asymptomatic patients.

Cue Health anticipates it will be manufacturing more than 100,000 tests per day by this summer. The test also received a CE Mark last month.

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