To embed, copy and paste the code into your website or blog: On December 15, 2020, the U.S. Food and Drug Administration (FDA) finally issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test that detects fragments of proteins on the SARS-CoV-2 virus from a nasal swab sample collected from any individual two years of age or older. 1 As voiced by FDA Commissioner Stephen M. Hahn, M.D., this is “a major milestone in diagnostic testing for COVID-19.” By authorizing this test as an OTC product, the FDA makes the Ellume COVID-19 Home Test available at places like retail drug stores, substantially expanding American consumers’ access to COVID-19 testing and reducing the burden on laboratories. For the first time, without the need for a prescription, consumers can get tested for COVID-19 from the safety of their own homes and find out their results in as little as 20 minutes. According to the FDA, Ellume expects to produce more than three million tests in January 2021.