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FDA authorizes Washington University’s new saliva-based COVID-19 test

FDA authorizes Washington University’s new saliva-based COVID-19 test

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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.

Gov. Mike Parson, speaking to reporters Wednesday, called the tests a “game changer” and suggested they would be used in Missouri.

“A new, saliva-based COVID-19 test developed in Missouri has been approved for use by the FDA,” Parson said. “This test, developed by researchers at Washington University, is a major development in testing technology.”

He said the new device would help increase the state’s testing volume and improve processing times.

Head said a “definite advantage” of the new test is that it doesn’t require RNA extraction, which “in addition to adding some time and cost to the test, it also can be a bottleneck for supply chains.”

He said the new test reduces the cost by removing the RNA extraction step and “also helps reduce the time to process” the test.

Washington University isn’t the first to develop a saliva test. Both Yale University and the University of Illinois at Urbana-Champaign both received emergency authorizations from the FDA for their saliva tests.

Saliva tests are less intrusive than nasal swab tests.

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"We easily will hit six-figure numbers in terms of the number of cases," Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said Friday night. "And the deaths are going to go up precipitously in the next three to four weeks."

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