FDA authorizes Washington University’s new saliva-based COVID-19 test | Coronavirus
FILE – In this July 24, 2020, file photo, healthcare worker Rahaana Smith instructs passengers how to use a nasal swab, at a drive-thru COVID-19 testing site at the Miami-Dade County Auditorium, in Miami. U.S. health officials have sparked a wave of confusion after posting guidelines that coronavirus testing is not necessary for people who have been in close contact with infected people. (AP Photo/Wilfredo Lee, File)
JEFFERSON CITY — The U.S. Food and Drug Administration has authorized a saliva-based COVID-19 test developed by researchers at Washington University in St. Louis and Fluidigm Corp., a San Francisco biotech company.
The company asked the FDA in June to fast-track approval of the test by granting an emergency use authorization. It announced late Tuesday the FDA had greenlighted the test; its shares soared Wednesday on the news, closing up 30%.
Jim McKinney, spokesman for the FDA, confirmed Wednesday that the agency authorized the test the day before.
Richard Head, professor of genetics at Washington University and director of the Genome Technology Access Center, said the test device is shaped like a small tube with a funnel attached at the top.
“Basically we ask people to deposit a saliva sample in through the funnel. It’s that simple,” he said. “We refer to it as ‘pool and drool’ as opposed to spitting or coughing or generating phlegm. We really just want the saliva from the mouth, not any sort of phlegm from the back of the throat.”
Head said the university laboratory, once its testing apparatus is scaled up, could process up to 5,000 tests per day. He said test processing could be replicated in other labs as well.
