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.
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.
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