U of I Walks Back Statement on FDA Authorization For Saliva-Based COVID Test

By Benjamin Cox on October 1, 2020 at 9:35am

The University of Illinois at Urbana-Champaign’s saliva based COVID-19 test has never received emergency use authorization from the US Food and Drug Administration, despite prior claims that it did, according to Illinois Newsroom.

The university has been using the test since July to test its student and staff weekly to keep the campus open. The samples are analyzed at the university’s labs, with more than 400,000 processed to date. According to Illinois Newsroom’s report, more than 2,000 positive COVID-19 cases have been identified at the school.

On August 19th, the university announced in a press release that they had begun performing the test under an approved FDA emergency use authorization. Governor J.B. Pritzker held a press conference on that same day also announcing the news.

An anonymous source from the FDA told Illinois Newsroom on Tuesday that the school never has operated under the emergency use nor had they ever received one. U of I spokesperson Robin Kaler told Illinois Newsroom that the school relied upon a bridging study being conducted with Yale University, which had received the emergency use on August 15th. Kaler says that the FDA called to ask them to correct the information this month. The August announcement from the U of I claiming the test had FDA authorization received a flurry of media coverage at both the local and national level, including from the New York Times, CNN, WebMD and Science along with coverage from several Illinois media outlets.

According to a press conference at the University on Monday, U of I chemist Martin Burke, who helped develop the campus’ saliva-based COVID-19 test, says the school is continuing to work toward EUA approval for its COVID-19 test. Although federal guidance no longer requires the school to seek FDA approval, Burke says they are continuing to work towards the approval to make the test nationally accessible.