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
美国食品药品管理局解决了与延迟批准 Lucira Health 的 COVID-19 和流感家庭测试有关的 “错误信息”
- 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.
- 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.
- 美国食品和药物管理局提供了有关该机构就紧急使用授权（EUA）的互动和决策的更多信息 Lucira Health Inc的 （场外交易代码：LHDXQ）COVID-19 和流感家庭测试。
- 该声明是由于担心该机构批准EUA的时间和时间及其破产申请的时间和时间，后者称EUA的延迟给该公司造成了财务打击。
- 在一份投资者报告中，Lucira将Covid和流感在家联合测试归咎于FDA的 “漫长” 授权程序。
- Lucira于去年5月向美国食品和药物管理局申请批准其新测试，预计将在流感季节开始前的夏末获得大拇指。去年8月，加拿大批准了Lucira的测试。
- 在Lucira申请破产两天后，FDA终于批准了Lucira的测试，并且已经过了流感季节的高峰期。
- 声明说，该机构在首次提交的测试文件中发现了一种可能对使用者构成风险的有毒物质。最终，该公司重新设计了测试。
- 此外，EUA的请求仅包括九份甲型流感阳性临床样本，FDA认为这些样本不足以确定测试性能和支持授权。
- 当Lucira重新提交时，该公司提供了35个样本，而不是要求的50个。
- “美国食品和药物管理局没有收集更多样本，而是与我们在美国国立卫生研究院（NIH）独立测试评估计划（ITAP）的合作伙伴合作，评估了该公司生产已知质量测试的能力。尽管提供的甲型流感阳性样本数量低于要求的数量，但这些数据仍支持授权，” 声明中写道。
- 由于当时流感的乙型流感病例不足，美国食品和药物管理局使用了Lucira授权的即时检测数据，其中包括以前流感季节的乙型流感样本。
译文内容由第三方软件翻译。
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