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.
Where the legal industry reads first.
Enjoyed this article? Get the biggest legal industry updates, deals, appointments, insights and expert interviews in your inbox, free.
No spam. Unsubscribe anytime.From Legal Desire
Is your firm the one being cited, or the one being skipped?
We ran the test. On several everyday legal questions, software companies are answering and law firms are not. We help firms fix that, and we build the technology behind the practice.
The advising firms, the named deal team, the value and the parties, with every other announced deal by the same firms and lawyers. Open the deal record
