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December 17, 2020

FDA Authorizes Over-the-Counter At-Home COVID-19 Test

On December 15, the FDA issued an emergency use authorization (EUA) for the Ellume COVID-19 Home Test. This is the first fully at-home diagnostic test for COVID-19 that does not require a prescription. Ellume is expecting to produce more than three million tests in January 2021; the tests will be available for purchase at drug stores.

Consumers will download an app to their smartphone that walks the user through the test, which is performed via a nasal swab on individuals who are at least two years of age. The results are then delivered to the individual’s smartphone in as little as twenty minutes. As necessary, the results will also be sent to the appropriate public health authorities to monitor disease prevalence. This test is not as sensitive as tests that are run in a lab, but the ability to perform a rapid response test at home provides another option to ease the burden on laboratories and testing supplies.