University of Illinois COVID test gets emergency FDA approval

The U.S. Food and Drug Administration has granted emergency use authorization of the saliva-based COVID-19 test developed and now in use at the University of Illinois, Gov. J.B. Pritzker announced today during a press conference updating the latest developments in the state’s pandemic response.

“Expanding our breakthrough, saliva-based testing will be a real game-changer, providing fast and efficient results that will protect lives and livelihoods,” U of I System President Tim Killeen said today. 

The test was developed in a matter of a few months by researchers in Urbana-Champaign as a way to quickly test returning faculty, staff and students, U of I Chancellor Robert J. Jones said today. On Monday, the U of I tested 10,000 people at the school, representing 1.3 percent of all tests in the nation that day, Jones said. 

The testing will be rolled out by a new organization, Shield T3, a limited liability company, governed by a nine-member board of managers chosen by the U of I Board of Trustees. 

U of I chemistry professor Dr. Martin Burke, who leads the saliva testing development team, said at the press conference that the FDA authorization was granted through a bridging study with Yale University School of Public Health’s saliva test. On Aug. 15, the FDA announced it granted Yale’s test emergency use authorization. 

The U of I test is very similar to Yale’s test, but the U of I test is potentially more scalable and the university has brought costs per test down to around $10 a test, said Burke, associate dean for research at the Carle Illinois College of Medicine.  

U of I’s CLIA-certified lab received the authorization under the Yale authorization and “any other CLIA-certified labs that would like to use the I-COVID protocol can perform similar bridging studies to the FDA EUA granted to Yale School of Public Health,” according to a statement from the U of I.

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