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BioWorld - Monday, February 23, 2026
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Home » FDA authorizes lateral flow antigen test as first OTC fully at-home test for COVID-19
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FDA authorizes lateral flow antigen test as first OTC fully at-home test for COVID-19

Dec. 15, 2020
By Mark McCarty
In what U.S. FDA commissioner Stephen Hahn billed as “a major milestone” in testing for the COVID-19 pandemic, the FDA has granted an emergency use authorization (EUA) to Ellume Ltd., of East Brisbane, Australia, for the company’s COVID-19 home test. The rapid lateral-flow test for antigen detection can be obtained without prescription and will return results to the at-home user in 20 minutes, according to the FDA’s Dec. 15 statement.
Medical technology Regulatory Diagnostics Digital health Mobile/smartphone app Coronavirus FDA

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