Morrison & Foerster secured an Emergency Use Authorization (EUA) from the U.S. Food Drug Administration (FDA) for client BGI Genomics for its Real-Time SARS-CoV-2 Test in under two weeks.
BGI’s Real-Time SARS-CoV-2 Test detects novel coronavirus with high sensitivity and a three hour turnaround time. The EUA allows the test to be available in the United States immediately for high-volume testing capabilities and to quickly diagnose patients.
In addition to this authorization being vital to serving the public health during the global COVID-19 pandemic, it is the first-ever FDA approval received by BGI Genomics.
The MoFo team advising BGI Genomics on this matter included FDA partner Bethany Hills and Financial Services partner Jiang Liu; and associates Anthony Parenti, Keunbong Do, and Hilary Hoffman; and scientific analyst Liz Newman.