FDA Approval Brings Some Good News For Bankrupt Lucira Health

  • Friday, the FDA issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test to differentiate and detect influenza A and B. 
  • Lucira Health Inc's LHDX COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes. 
  • The single-use test can be purchased without a prescription and performed entirely at home using nasal swab samples self-collected by individuals ages 14 years or older or collected by an adult for individuals two years of age or older. 
  • Related: Within Two Years Of Public Debut, COVID-19 Test Maker Files For Bankruptcy.
  • In individuals with symptoms, the Lucira COVID-19 & Flu Home Test correctly identified 99.3% of negative and 90.1% of positive Influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples, and 99.9% of negative Influenza B samples. Since there are currently not enough cases of Influenza B circulating to include in a clinical study, validation confirmed that the test could identify the virus in contrived specimens.
  • The EUA requires Lucira to continue to collect samples to study the test's ability to detect Influenza B in real-world settings.  
  • Price Action: LHDX shares are up 287.80% at $0.54 during the premarket session on the last check Monday.
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