Hogan Lovells secures FDA emergency use authorization for Lucira Health for breakthrough OTC COVID-19 and flu test

Press releases | 07 March 2023

Washington D.C., 7 March 2023 – Global law firm Hogan Lovells counseled Lucira Health, Inc. (Lucira), a medical technology company focused on the development of innovative infectious disease tests, in securing U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) for its Lucira COVID-19 & Flu Home Test for over the counter (OTC) use. The test represents a breakthrough in diagnostic testing as the first at-home combination COVID-19 and Flu test, and as the first flu test for OTC use in the United States. More about the EUA, which was issued 27 February, can be found here.

The Lucira COVID-19 & Flu Home Test utilizes the same platform and device design as Lucira’s commercialized FDA authorized COVID-19 test to provide independent diagnoses for COVID-19, Flu A, and Flu B. It is a molecular test that demonstrated similar performance for COVID-19 and Influenza A and B compared to highly sensitive lab-based PCR tests in clinical trials.

According to the FDA, the EUA represents the agency’s ongoing commitment to increase the availability of appropriately accurate and reliable at-home diagnostic tests, including for COVID-19, and to facilitate access to these tests for all Americans.

The Hogan Lovells team for Lucira Health included Washington D.C.-based Medical Device & Technology partners Jonathan Kahan, Mike Heyl, Jodi Scott, and Randy Prebula; senior director Susan Tiedy-Stevenson; and associate Erkang Ai.

For more information from FDA, please see here.