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FDA Authorizes First Full At-Home Test for the Detection of SARS-CoV-2

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On November 17, 2020, FDA issued the long-awaited first emergency use authorization (EUA) for a COVID-19 diagnostic test for self-testing at home. The test, the Lucira COVID-19 All‑In‑One Test Kit, can be conducted completely at home by anyone age 14 or over, by collecting a nasal swab and placing it in a vial, which is then placed into a battery-operated test unit that provides results in 30 minutes or less. 

We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.