FDA Addresses 'Misinformation' Concerning Delayed Approval Of Lucira Health's COVID-19 & Flu Home Test

  • The FDA provided additional information about the agency's interactions and decisions regarding the emergency use authorization (EUA) of Lucira Health Inc's LHDXQ COVID-19 & Flu Home test.
  • The statement comes due to concerns about the agency's length and timing of the EUA clearance and its bankruptcy filing, which said the delay in EUA financially hit the company.
  • In an investor report, Lucira blamed the FDA's "protracted" authorization process for its combination Covid and flu at-home test. 
  • Lucira applied to the FDA for authorization of its novel test last May and expected to receive a thumbs-up by the end of summer before the flu season started. Canada authorized Lucira's test last August.
  • The FDA finally authorized Lucira's test two days after it filed for bankruptcy and past the flu season peak.
  • The statement said the agency had found a toxic substance in the test's first submission that could pose a risk to users. Eventually, the company redesigned the test.
  • In addition, the EUA request included only nine positive influenza A clinical samples that FDA considered insufficient to determine test performance and support authorization.
  • When Lucira resubmitted, the company included 35 samples instead of the requirement of 50.
  • "In lieu of collecting additional samples, the FDA worked with our partners at the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP) to evaluate the company's ability to manufacture tests of known quality. This data supported authorization even with the lower than requested number of positive influenza A samples that were provided," the statement reads.
  • Since there were not enough cases of influenza B circulating at the time, the FDA used data from the authorization of Lucira's point-of-care test, which included influenza B samples from previous flu seasons.
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