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BioWorld - Sunday, May 3, 2026
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Home » Cue Health’s COVID-19 at-home molecular test receives FDA EUA for OTC sales
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Cue Health’s COVID-19 at-home molecular test receives FDA EUA for OTC sales

March 8, 2021
By Annette Boyle
Cue Health Inc. became the first company to offer COVID-19 molecular testing for home use without a prescription following U.S. FDA emergency use authorization on March 5, 2021. The San Diego-based company’s isothermal nucleic acid amplification test (NAAT) detects RNA from SARS-CoV-2 virus present in the nostrils. “The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use provides access to accurate and reliable testing at-home, without a prescription.”
Medical technology Regulatory Diagnostics Coronavirus FDA

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