Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is 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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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.”

Cue COVID-19 Test for Home and Over The Counter (OTC) Use test is authorized for non-prescription home use for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens collected with the Cue Sample Wand. This test is intended for use in 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) that is downloaded onto compatible mobile smart devices, like a smart cell phone. 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. The mobile application requires individuals to create an account, and in the future will be updated to include capability to report 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% of positive samples from individuals known to have symptoms and correctly identified 100% 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.”

The FDA has authorized more than 330 tests and collection kits for a variety of uses, users and locations to provide a wide array of test options. FDA has also prioritized review and authorization of EUA requests taking into account a variety of factors, as discussed in the Emergency Use Authorization of Medical Products and Related Authorities Guidance, such as the public health need for the product and the availability of the product, with the goal of expanding overall US testing capacity and patient access to tests. The FDA has, for example, prioritized review of EUA requests for tests where authorization would increase testing accessibility (e.g., point-of-care (POC) tests, home collection tests, and at-home tests) or would significantly increase testing capacity (e.g., tests that reduce reliance on test supplies and high-throughput, widely distributed tests). Tests with EUA authorization can be found on our website at In Vitro Diagnostic EUAs.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation and for regulating tobacco products.

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