The Food and Drug Administration has granted Emergency Use Authorization (EUA) to the first at-home, over-the-counter (OTC) molecular nucleic acid amplification test to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The Cue COVID-19 Test for Home and OTC Use (Cue Health) is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens. It can be used by individuals 2 years of age and older with or without symptoms or other epidemiological reasons to suspect COVID-19.
The authorized test includes: the single-use Cue COVID-19 Test Cartridge, the single-use Cue Sample Wand nasal swab, the Cue Cartridge Reader (used by the Cue Health Monitoring System, provided separately), and the Cue Health Mobile Application. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App in about 20 minutes.
According to the FDA, the test correctly identified 96% of positive samples from individuals known to have symptoms and 100% of positive samples from individuals without symptoms.
“For the first time, consumers can access laboratory-grade testing at home,” said Ayub Khattak, Co-Founder and CEO of Cue. “With this FDA authorization, we are one step closer to achieving our mission of making molecular diagnostic testing available to anyone, anywhere, at any time through a connected healthcare delivery ecosystem.”
The Company expects to produce more than 100,000 tests per day by summer 2021.
For more information visit cuehealth.com.
1. Coronavirus (COVID-19) Update: FDA issues authorization for first nolecular non-prescription, at-home test. [press release]. Silver Spring, MD: The US Food and Drug Administration: March 5, 2021.
2. FDA authorizes Cue Health’s COVID-19 Test for At-Home and Over The Counter Use. [press release]. San Diego, CA: Cue Health; March 5, 2021.