The Department of Genetics and McDonnell Genome Institute (MGI) at Washington University School of Medicine, in collaboration with biotech company Fluidigm, are developing a saliva test to detect the SARS-CoV-2 virus. Fluidigm this week received emergency use authorization (EUA) from the FDA for the test. The FDA authorization allows the university to perform the test.
Washington University has filed a separate EUA application with the FDA that is still pending.
The milestone marks a big step forward for both groups. Researchers in the Department of Genetics and MGI are developing a rapid test that could screen large numbers of people using saliva samples. People could collect samples themselves and forgo an uncomfortable nasal swab.
“This is a significant advance in COVID-19 testing that is a simpler, faster and more economical test that can greatly expand our ability to detect the level of COVID-19 infection within the community via large-scale population screening for the SARS-CoV-2 virus,” said Jeffrey Milbrandt, MD, PhD, the James S. McDonnell Professor and head of the Department of Genetics and the McDonnell Genome Institute.
“There’s an urgent need to simplify testing for COVID-19 so that people who are infected can be easily and quickly identified,” said Richard Head, a professor of genetics and director of the Genome Technology Access Center at the McDonnell Genome Institute. “The test we developed doesn’t require RNA extraction, a time-consuming and expensive step necessary for other COVID-19 tests. Our team found the right recipe, so to speak, to allow direct testing for the virus in saliva samples, and it works exceptionally well.”
Key team members who developed the test include Lauren Burcea, a research lab supervisor; Christopher Sawyer, a research lab manager; Shelly O’Laughlin, a clinical lab manager; Rob Mitra, PhD, the Alvin Goldfarb Distinguished Professor of Computational Biology; William Buchser, PhD, an assistant professor genetics; Michael Heinz, a manager of research & core services; Robert Fulton, an assistant professor of genetics; Lucinda Fulton, an instructor in genetics; Catrina Fronick, a senior research engineer; Matthew Lalli, PhD, a postdoctoral research associate; Josh Langmade, a staff scientist; Xuhua Chen, a staff scientist; and Lisa Cook, a research lab manager; Jane O’Halloran, MD, assistant professor of medicine; and Stacy House, MD, PhD, assistant professor of emergency medicine.
Read more about the test in this press release.