In August, Pritzker said FDA had given emergency use authorization to the U. of I.’s saliva-based COVID-19 test. FDA now says it never issued any such OK.
With great fanfare, Gov. J.B. Pritzker announced over the summer that a new saliva-based COVID-19 test developed by the University of Illinois had been granted emergency use authorization by the U.S. Food and Drug Administration, calling this “some of the best news” since the pandemic began.
The FDA, however, says the university’s test has never operated under an emergency use authorization, as the governor and university leadership have repeatedly claimed.
“The University of Illinois is not authorized under an umbrella emergency use authorization, and they have not had an emergency use authorization,” an FDA spokesman said.
The university can continue to administer its saliva-based test — which has already been used to test tens of thousands on campus and in the university community — but had to change the language it uses regarding FDA regulation.
The university blamed the situation on confusion over FDA protocols. The university said it believed the saliva-based test had earned emergency use authorization through a study comparing it with a separate FDA-authorized test developed by Yale University researchers.
On Aug. 19, a university news release stated that the school is “now performing its new rapid, saliva-based COVID-19 test under the umbrella of an approved FDA Emergency Use Authorization.”
The statement went on to say the university performed a bridging study to a recently approved FDA emergency use authorization “showing that the Illinois test performs at least as well as the recently approved saliva-testing protocol.” The news release referenced a similar COVID-19 saliva test recently developed by Yale School of Public Health researchers, which did receive FDA emergency use authorization.
At a news conference, Pritzker had called the U. of I.’s test potentially “game-changing.” The news was reported by media outlets nationwide, including the Chicago Tribune.
University spokeswoman Robin Kaler said the university “conducted what we understood to be a bridging study,” based on the university’s understanding of the FDA’s May Policy for Coronavirus Disease 2019 Tests During the Public Health Emergency, as well as a subsequent email from the FDA.
“You’ll note that at every step of the way, we were doing our very best to follow the guidance and direction from the FDA and that we have never performed our test out of regulatory compliance,” she said in an email.
But the FDA in a recent phone conversation asked the university to stop using the terms “bridging study” and “umbrella,” according to Kaler.
In a follow-up email on Sept. 21, an FDA official highlighted in yellow various statements from university websites and blogs about the saliva test “that we find to not appropriately represent the status of your test and which may be contributing to the misunderstandings regarding your test.”
“We understand that some of this confusion may have stemmed from a misunderstanding of the word ‘bridging,’” the email from the FDA official added. “Your test is not considered within the authorization of the Yale SalivaDirect (emergency use authorization), nor has it received its own authorization from the FDA.”
University officials said they have since revised the wording on various online documents, including information on campus COVID-19 testing on the university website.
“We immediately updated the language to be consistent with their direction,” Kaler said.
The email from the FDA also pointed out other online links outside of the university “where the authorization status of your saliva test seems to be mischaracterized.” One of those links was to an Aug. 19 tweet by Pritzker stating that the FDA “has just given the green light under their Emergency Use Authorization powers.”
Pritzker’s office referred questions about FDA authorization to the university.
“If the regulatory situation has changed since the announcement, those questions should be answered by the University of Illinois,” a spokeswoman for the governor said in an email.
Since the university’s August announcement, the federal government has changed its guidelines for laboratory-developed tests like the one created by the U. of I., no longer requiring FDA emergency use authorization if the lab is appropriately federally regulated, according to the U.S. Department of Health and Human Services.
Despite the federal guidance change, university officials say they are still seeking FDA emergency use authorization for the saliva test.
The university in early July began using the saliva-based test, which was developed in its laboratory that’s CLIA-certified, meaning it’s approved and regulated by federal agencies.
Medical experts say saliva-based tests have many benefits compared with typical nasal swab tests, including requiring less personal protective equipment for clinicians and fewer testing supplies amid a national shortage. The test also tends to be less uncomfortable for patients than nasopharyngeal swab tests.
So far, 38,000 people have been tested using the university’s saliva-based test, Kaler said.
“Our test continues to play a critical role in allowing us to monitor and prevent the spread of COVID-19, and our seven-day positivity rate is at 0.36%,” she said.
eleventis@chicagotribune.com
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