FDA Issues EUA to First OTC Home Molecular COVID-19 Test

The U.S. Food and Drug Administration (FDA) issued emergency use authorization for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The Cue test is a molecular nucleic acid amplification test (NAAT) that detects SARS-CoV-2 virus genetic material present in the nostrils. It’s the first molecular test authorized for at-home use without a prescription. 
 
“The authorization of this new diagnostic test underscores FDA’s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans,” acting FDA Commissioner Janet Woodcock, M.D. told the press. “The FDA will continue to expand Americans’ access to testing to help us in the fight against this pandemic, which has claimed over half a million lives in the United States.”
 
The test is authorized for non-prescription home use to qualitatively detect SARS-CoV-2 nucleic acid in nasal swab specimens collected with the Cue Sample Wand. This test is meant for adults (self-swabbing) or children two years of age or older (swabbed by an adult) 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 (App) downloaded onto compatible mobile smart devices. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results to the Cue Health App in about 20 minutes. The mobile application requires an account, and in the future will be updated to include reporting test results as appropriate to public health authorities to monitor disease prevalence.
 
Cue COVID-19 Test for Home and Over The Counter (OTC) Use correctly identified 96 percent of positive samples from individuals with symptoms and correctly identified 100 percent of positive samples from individuals without symptoms. Cue Health expects to produce more than 100,000 tests per day by summer 2021.
 
“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use provides access to accurate and reliable testing at-home, without a prescription. The FDA will continue to work collaboratively with test developers to advance effective testing options for doctors, clinicians, and the public.”