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Abbott's Molecular Assay Gets FDA EUA Approval To Detect SARS-CoV-2 And Flu In One Test

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  • The FDA has granted Emergency Use Authorization (EUA) for Abbott Laboratories' (NYSE: ABT) Alinity m Resp-4-Plex molecular assay to detect and differentiate SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) in one test.
  • The Alinity m Resp-4-Plex test can be conducted with one swab specimen.
  • The company announced that EUA for the Alinity m SARS-CoV-2 test had been updated to include an asymptomatic claim, detecting COVID-19 in individuals who do not have symptoms.
  • EUA was also updated to include a pooling claim, which allows testing up to five samples simultaneously. 
  • The Alinity m system can run up to 1,080 tests in a 24-hour period based on laboratory practice and workflow. 
  • Price Action: ABT shares are trading 0.83% lower at $115.06 in market trading hours on the last check Friday.
 

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Posted-In: Covid-19Biotech News Health Care FDA General

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