BioFire’s Covid Test Panel Receives FDA Marketing Authorization

March 17, 2021, 9:05 PM UTC

FDA granted marketing authorization to BioFire’s Respiratory Panel 2.1 (RP2.1), a Covid-19 diagnostic test.

  • The test is able to simultaneously detect and identify multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs
  • The diagnostic test already had an Emergency Use Authorization
  • Product is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency

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To contact the reporter on this story:
Linly Lin in San Francisco at llin153@bloomberg.net

To contact the editor responsible for this story:
Chakradhar Adusumilli at cadusumilli@bloomberg.net

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