On Jun. 6, 2023, the U.S. Food and Drug Administration (FDA) granted granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of upper respiratory infection.

This test is the first at-home over-the-counter (OTC) test for COVID-19 to be granted marketing authorization using a traditional premarket review pathway and the first ever at-home test authorized using a traditional premarket review pathway for any respiratory illness.

As with all rapid tests, there is a risk of false positive and false negative results. Individuals who test positive for SARS-CoV-2 should take appropriate precautions to avoid spreading the virus and should seek follow-up care with their physician or healthcare provider as additional testing may be necessary. Negative results should be confirmed by a lab-based molecular test if necessary for patient management. Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 or another respiratory infection and should seek follow up care with their healthcare provider.