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FDA makes unusual ‘misinformation’ comment on Lucira’s EUA for COVID-19 and flu test

Published on 10/03/23 at 11:48am

The FDA has made a rare comment about what happened at Lucira Health’s Emergency Use Authorization (EUA) filing for its at-home COVID-19 and flu test, as part of the agency’s “commitment to address misinformation”. This comes just a matter of weeks after the EUA was issued and the company filed for Chapter 11 bankruptcy.

The FDA has declined to comment or clarify what it meant by misinformation, however the statement follows a tweet from one of Lucira’s co-founders in February. The tweet questions the agency’s length and timing of the EUA clearance and its bankruptcy filing, claiming that the delay in EUA financially impacted the company.

The FDA’s press release states: “Following the EUA request from Lucira Health for their over-the-counter (OTC) COVID-19 & Flu Test, the FDA determined the test posed a risk to consumers due to a toxic substance identified in one of the test components, making it unsuitable for at-home use. Eventually, the company redesigned the test to address this problem. In addition, the EUA request included only nine positive influenza A clinical samples – an amount we found was insufficient to adequately determine test performance and support authorisation by the FDA.”

Lucira later filed for bankruptcy, referencing the EUA process: “The Company anticipated an EUA for an OTC indication on the COVID-19 and Flu test in August 2022, though the FDA’s approval process became protracted, resulting in high expenditures without new revenue from the combined test kit during the 2022-2023 flu season. As such, the Company’s operations were significantly impacted, leading to the Chapter 11 filing and sale process.”


Betsy Goodfellow

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