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

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

美國食品和藥物管理局解決有關延遲批准 Lucira 健康的 COVID-19 和流感家庭測試的「錯誤信息」
Benzinga ·  2023/03/10 11:53
  • The FDA provided additional information about the agency's interactions and decisions regarding the emergency use authorization (EUA) of Lucira Health Inc's (OTC: 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.
  • FDA 提供了有關該機構在緊急使用授權（EUA）方面的互動和決定的其他信息 盧西拉健康公司 （場外交易：LHDXQ）COVID-19 和家用流感 test。
  • 該聲明是由於對該機構的長度和時間進行 EUA 清關以及其破產申請的擔憂，這表示歐盟的延遲在財務上對公司造成了影響。
  • 在一份投資者報告中，盧西拉（Lucira）歸咎於 FDA 的「長期」授權流程，以進行 Covid 和流感在家中進行聯合 test。
  • Lucira 去年 5 月向 FDA 申請了其新型 test 的授權，並預計在夏季結束前將在流感季節開始之前獲得大拇指。加拿大去年八月批准了盧西拉的 test。
  • FDA 終於批准了 Lucira 的 test，在申請破產和過去流感季節高峰後的兩天。
  • 該聲明稱，該機構在測試的第一次提交中發現了可能對用戶構成風險的有毒物質。最終，該公司重新設計了 test。
  • 此外，歐盟的要求僅包括九個 A 型流感陽性臨床樣本，這些樣本被 FDA 認為不足以確定 test 性能和支持授權。
  • 當 Lucira 重新提交時，該公司包括 35 個樣本，而不是 50 個要求。
  • 「為了取代收集更多樣本，FDA 與美國國家衛生研究院（NIH）獨立測試評估計劃（ITAP）的合作夥伴合作，以評估公司製造已知質量測試的能力。即使提供的甲型流感陽性樣本數量低，該數據也支持授權。」
  • 由於當時沒有足夠的乙型流感病例流行，因此 FDA 使用了 Lucira 護理點 test 授權的數據，其中包括先前流感季節的乙型流感樣本。
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