MedTech Dive November 23, 2022
Nick Paul Taylor

Dive Brief:

  • The Food and Drug Administration has expanded the U.S. COVID-19 testing arsenal ahead of a potentially tough winter, granting an emergency use authorization (EUA) to one flu combination assay and two rapid antigen tests for SARS-CoV-2.
  • Lucira Health secured the authorization for the combination COVID-19 and flu kit, specifically its nucleic acid amplification test, after achieving at least 90% agreement with highly sensitive tests of the two pathogens.
  • The FDA also awarded an EUA to antigen tests from Azure Biotech and CorDX, bringing the number of tests and sample collection devices authorized by the agency up to 439.

Dive Insight:

There are conflicting forecasts about how heavy a burden SARS-CoV-2 and other respiratory pathogens will place...

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Topics: FDA, Govt Agencies, Healthcare System, Patient / Consumer, Provider, Public Health / COVID
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