FOR IMMEDIATE RELEASE

March 7, 2023

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health

As part of the FDA’s commitment to address misinformation, we are providing additional information about the agency’s interactions and decisions regarding the emergency use authorization (EUA) of Lucira Health’s COVID-19 & Flu Home test.

As the standard for EUA is different from the typical, non-emergency, marketing authorization, we made recommendations in publicly available EUA templates to assist developers with the data and information to submit to the FDA in support of a COVID-19 EUA. The relevant template recommended performing a prospective clinical study and including 50 influenza A positive clinical samples, 30 influenza B positive clinical samples, and 50 SARS-CoV-2 positive clinical samples. In addition to being publicly available on the FDA website, this information was routinely conveyed to test developers through pre-EUA interactions, as well as during recurring public virtual town halls.

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 9 positive influenza A clinical samples – an amount we found was insufficient to adequately determine test performance and support authorization by the FDA.

Lucira Health submitted a new EUA request at the end of 2022 that included 35 positive influenza A samples and the SARS-CoV-2 data from their previously authorized COVID-19 test that did not detect influenza. 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. Since there are currently not enough cases of influenza B circulating to include in a clinical study, to evaluate the test’s ability to detect and differentiate influenza B, the FDA relied upon information from the recent authorization of the company’s point-of-care test, which included influenza B samples from prior flu seasons.