U of I Dials Back Statements About FDA Authorization For Its COVID-19 Test
The University of Illinois at Urbana-Champaign’s saliva-based COVID-19 test has never operated under emergency use authorization from the U.S. Food and Drug Administration, despite prior claims that it did, an FDA spokesperson tells Illinois Newsroom.
Since July, the U of I has used a COVID-19 test it developed to test all students and staff at least weekly in the hopes of safely reopening the Urbana campus. Saliva samples are analyzed at the U of I’s own labs, and to date, more than 400,000 COVID-19 tests have been processed. Since the semester started on Aug. 24, more than 2,000 positive COVID-19 cases have been identified through the campus’ testing program.
On Aug. 19, campus officials announced in a press release that the U of I had begun performing its saliva-based test under the umbrella of an approved FDA emergency use authorization. Illinois Gov. J.B. Pritzker held a press conference that same day to share the news.
But in response to questions from Illinois Newsroom about the EUA status of U of I’s saliva test, an FDA spokesperson said in an email: “The University of Illinois is not authorized under an umbrella EUA, and they have not had an EUA.”
In an emailed statement, Robin Kaler, a spokesperson for the U of I’s Urbana campus, says faculty and staff relied on an Aug. 5 email from the FDA stating that the campus could perform a “bridging study” — comparing the efficacy of its own saliva test to one that has been authorized by the FDA.
Kaler says the university compared its saliva test to one created at Yale University, which received emergency use authorization from the FDA on Aug. 15. After the bridging study was completed, the university’s regulatory and compliance consultant advised faculty and administrators that they could claim that the university’s COVID-19 test was operating under the umbrella of the test created by Yale University.
Kaler says the FDA reached out to the U of I via phone this month and asked the university to discontinue using the terms “bridging study” and “umbrella.” At that point, the university updated its language to remove references to its test operating under the umbrella of an FDA EUA test.
“We immediately updated the language to be consistent with their direction,” Kaler said in an email.
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. (Illinois Newsroom also reported the announcement and has since added a correction to the story.)
At a press conference held on Sept. 28 on the Urbana campus, Illinois Newsroom asked U of I chemist Martin Burke, who helped develop the campus’ saliva-based COVID-19 test, if he spoke in error when the university announced that the test had received EUA status from the FDA.
Burke said when the announcement was made, it was “fully consistent with our understanding of the [federal] guidelines at the time,” that the guidance regarding laboratory developed tests had since changed, and that the university continues to work toward EUA approval for its COVID-19 test.
During his Aug. 19 news conference, Gov. J.B. Pritzker lauded the university for its testing efforts, and repeated the claim that the test had received EUA approval from the FDA.
“The University of Illinois has just today received emergency use authorization from the Food and Drug Administration to run their saliva-based COVID test at the University of Illinois Urbana-Champaign lab,” Pritzker said on Aug. 19. “This news puts the University of Illinois — and the entire state — on the cutting edge of testing innovation.”
A spokeswoman for Pritzker did not explain why the governor claimed the test had received EUA status during the Aug. 19 news conference. In an emailed statement to Illinois Newsroom on Sept. 29, she wrote that: “At the time of the announcement, the University of Illinois had completed a successful bridging study to an already-existing EUA and certified with the federal government that it had followed all the steps necessary to begin running their saliva test. If the regulatory situation has changed since the announcement, those questions should be answered by the University of Illinois.”
U of I System President Tim Killeen echoed Pritzker’s statement on Aug. 19, saying “FDA’s approval” of the saliva test allows the U of I to “turbo-charge” efforts to expand the use of test, not only on other campuses, but in K-12 schools and other public and private institutions. In August, the U of I announced the creation of a new organization, Shield T3, a limited liability company the university created to expand its testing technology nationwide. The web post announcing the installment of board officers for the T3 initiative, as well as other campus websites, continue to state that the saliva test is being performed “under the umbrella of an Emergency Use Authorization approved by the Food and Drug Administration.”
Burke, the U of I chemist, said at the Aug. 19 press conference that the U of I’s test is similar enough to Yale’s SalivaDirect test “that we were able to perform a bridging study and thereby operate under the umbrella of that FDA EUA… Our test was in fact even more sensitive (and) this allowed our CLIA-certified lab director to then grant us umbrella coverage under the FDA EUA approval from the Yale team because our assay was shown to be non-inferior in our bridging study.”
(A CLIA-certified lab refers to a clinical laboratory regulated by federal agencies including the FDA, CDC and Centers for Medicare and Medicaid Services.)
Yale researcher Nate Grubaugh, who helped develop SalivaDirect, declined to comment on the matter, stating via email only that he thinks the U of I’s saliva testing program is “outstanding” and that the campus is “likely saving many lives.”
The language on the U of I’s press release about the FDA status of its saliva test remained unchanged through at least Sept. 1, according to snapshots taken by the digital archive website, Wayback Machine.
The snapshots suggest that some time between Sept. 1 and Sept. 25, a change in the press release was made. Without an explanation noted on the website, the campus changed the wording to no longer claim the saliva test was operating under FDA emergency use authorization.
It now states that the campus “validated its laboratory-developed test under CLIA by successfully comparing its performance to an FDA Emergency Use Authorized test.”
Although federal guidance no longer requires the U of I’s CLIA-certified lab to work toward emergency authorization through the FDA, Burke says the campus is continuing to work toward that end because it will make it easier for other labs to adopt the test and “make it broadly accessible throughout the country.”
So far, campus officials say the U of I has been contacted by 35 organizations, including other universities, expressing interest in adopting the campus’ Shield program, which involves testing, contact tracing and other mitigation measures.
Other CLIA-certified labs are able to adopt the U of I’s saliva-based COVID-19 test before it receives FDA authorization, and some already have, says U of I chemist Paul Hergenrother.
The updated federal guidance simply means that labs can now use laboratory-developed tests, like the U of I’s saliva-based test, and “operate under CLIA director approval indefinitely,” Hergenrother says. “The [emergency use authorization] just formalizes the protocol.”
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