FDA Grants Emergency Use Authorization for GW COVID-19 Test

August 13, 2020

On August 7, the U.S. Food and Drug Administration granted an Emergency Use Authorization (EUA) to a COVID-19 diagnostic test developed by scientists at the George Washington University (GW) Milken Institute School of Public Health (Milken Institute SPH). The test, developed by Cindy M. Liu, MD, PhD, MPH, and a team of scientists at Milken Institute SPH, relies on a powerful technique known as polymerase chain reaction to detect the virus that causes COVID-19.

An EUA allows the FDA to grant expedited approval to diagnostic tests and other products urgently needed to combat a public health threat, like the one posed by the SARS-CoV-2 virus. Starting in May, Liu and her team worked nearly around the clock to set up the new public health laboratory in GW’s Science and Engineering Hall.

“Dr. Liu and her team had to solve many complex scientific challenges as well as clear the FDA regulatory hurdles to pave the way toward testing on the GW campus,” said Lynn R. Goldman, MD, MS, MPH, the Michael and Lori Milken Dean of the Milken Institute SPH. “This EUA gives the university the ability to conduct rapid, accurate testing of our community. It represents an important accomplishment for the team and a major milestone on the road toward re-opening the university.”

GW will hold all classes online for the fall semester but will provide on campus housing for a limited number of students who have extenuating personal or academic circumstances. In addition, a limited number of faculty and staff will be regularly coming to campus to perform essential work.

Starting on Aug. 17, GW students, faculty and staff who will be on campus will get free nasal swab tests for the virus at weekly intervals. “Our goal is to provide testing for the GW campus seven days a week with results back in 24 hours,” said Liu, who is an associate professor of environmental and occupational health at Milken Institute SPH. “Rapid, accurate testing means GW will not have to rely on outside laboratories that have long delays in providing results.”

Fast test results are also the key to early identification of cases and containing the spread of SARS-CoV-2. “The EUA is a big step forward in keeping the GW community healthy and safe,” Liu said.