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December 16, 2020

Health Law Daily

FDA Issues Emergency Authorization For OTC Rapid At-Home Coronavirus Diagnostic Test

  • December 16, 2020

The New York Times (12/15, Wu) reports that the FDA “on Tuesday issued an emergency authorization for the country’s first coronavirus test that can run from start to finish at home without the need for a prescription.” Individuals “as young as 2 years old are cleared to use the test.” The Times adds, “Unlike many similar products, which are only supposed to be used by people with symptoms of COVID-19, this test is authorized for people with or without symptoms.”
      The AP (12/15, Perrone) reports that the “test looks for viral proteins shed by COVID-19, which is different from the gold standard tests that look for the genetic material of the virus.”
      HealthDay (12/15) reports, “The test uses an analyzer that connects with a smartphone app to help users perform the test and interpret results.” The “results are delivered by smartphone in as little as 20 minutes.”
      Among other sources covering the story are The Hill (12/15, Sullivan), Politico (12/15, Lim), NPR (12/15, Stein), MedPage Today (12/15, Walker), USA Today (12/15, Alltucker), Medscape (12/15, Brooks, Subscription Publication), and Bloomberg (12/15, Court).