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U Of I COVID-19 Test Receives FDA Emergency Use Authorization

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URBANA – The University of Illinois’ COVID-19 testing process has received Emergency Use Authorization from the federal Food and Drug Administration.  

Authorization was granted in a February 24 letter to the university from FDA Chief Scientist, Rear Admiral Denise M. Hinton. 

Ben Taylor, spokesman for Shield Illinois, the U of I’s program for marketing the testing process in the state, says the authorization will make possible the broad expansion of the saliva-based process beyond the U of I campuses.

“It provides partners with additional assurance that the test has been vetted and reviewed at the highest levels of regulation in our country,” said Taylor. “And it really gives people confidence that it is a good and valid and accurate test.”

Currently, 14 colleges and universities in Illinois (including Eastern Illinois University, Northern Illinois University and Millikin University in Decatur) are using the U of I test process for their students or employees. Two companies, ADM and Rivian, are also using the process. Taylor says several organizations told them they want to use the testing as well, once it receives Emergency Use Authorization.

The U of I says that as a result of the authorization, Governor J.B. Pritzker has released $20 million in federal CARES Act funding to expand the process to Illinois’ other public universities.

“I want to offer my gratitude to the scientists, researchers and healthcare workers at U of I who worked quickly to respond to the COVID-19 crisis, helping save lives and protect our neighbors throughout Illinois”, Pritzker was quoted as saying in a university news release.

Monday’s announcement comes more than six months after the University of Illinois first announced that its COVID-19 testing process qualified for the FDA’s Emergency Use Authorization. Last August, the university announced that its tests were being performed under an EUA through a “bridging study” to another process that had the authorization (later revealed as one developed by Yale University). But the FDA said it had not granted permission for the university to make that claim, which had been recommended by a consultant. The U of I stopped using the bridging study claim at the FDA’s request.

Organizations that use the U of I’ s saliva-based testing process must work with clinical laboratories which have been certified under federal Clinical Laboratory Improvement Amendments or CLIA. Taylor says the university worked with seven laboratories to establish CLIA-approved facilities to process the saliva tests.

COVID-19 is a rapidly evolving story, and we are working hard to bring you the most up-to-date information. We recommend checking the Coronavirus Information Center for the most recent numbers and guidance.

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Jim Meadows

Jim Meadows

Jim Meadows has been covering local news for WILL Radio since 2000, with occasional periods as local host for Morning Edition and All Things Considered and a stint hosting WILL's old Focus talk show. He was previously a reporter at public radio station WCBU in Peoria.

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