URBANA, Ill. (WCIA) — The University of Illinois has not obtained approval from the federal Food and Drug Administration for its saliva-based COVID-19 test, a spokesperson confirmed Wednesday.
The information is a back-tracking of an announcement made by Gov. JB Pritzker during an August 19 press conference, in which the governor said the university had received “Emergency Use Authorization” for the coronavirus test its scientists and researchers had developed.
The saliva testing method that the university developed is faster and more cost-effective than the current method of using a nasal swab, University of Illinois chemistry professor Dr. Martin Burke said during the conference, adding that studies showed it was just as effective. He and other officials touted the EUA’s ability to give the university the chance to “turbo-charge” efforts to expand the innovative testing beyond just the Urbana-Champaign campus. That potentially includes national expansion, as well distributing the test to schools of all types throughout the state— colleges, universities, secondary and primary schools, both public and private.
And on that same day, the UIUC newsroom posted an article about the testing, saying the tests were being performed “under the umbrella of an approved FDA Emergency Use Authorization.”
Nearly a month later, a spokesperson for the FDA confirmed to WCIA that the university had never received such approval.
University spokesperson Robin Kaler said the discrepancy was part of a misunderstanding with the FDA.
The testing had been developed within a CILA-certified laboratory on campus, which means, in short, that the laboratory is subject to federal standards that regulate facilities or sites that “test human specimens for health assessment or to diagnose, prevent, or treat disease.” Regulators for such sites include the FDA, Centers for Disease Control and Prevention, and Centers for Medicare and Medicaid Services.
Guidance from the FDA says that laboratory-developed tests (or LDTs) “do not need to undergo pre-market review by the FDA.”
“Those seeking approval or clearance of, or an emergency use authorization (“EUA”) for an LDT may nonetheless voluntarily submit a premarket approval application, premarket notification or an EUA request, respectively, but are not required to do so, and FDA will adjudicate those submissions,” the guidance reads. “
A test similar to the one the UI developed was granted EUA by the FDA on August 15, according to Yale News. Kaler said that the similarities led university officials to believe they could conduct a bridging study, in which the tests from both schools could be compared, and the UI’s covered under the EUA already granted to Yale.
“We also relied on an August 5 e-mail from the FDA advising us we could pursue our own EUA or satisfy one of a series of other options, one of which was: ‘You have completed bridging studies to a test that has been authorized by FDA.’ Based on that option and the published guidance, we conducted what our CLIA director approved as a bridging study,” Kaler wrote in an email to WCIA. Based on the explicit advice of our regulatory and compliance consultant, we described the study as a ‘successfully completed bridging study’ that placed our test “under the umbrella” of an approved EUA.”
But the FDA took issue with the university’s interpretation of that guidance.
Kaler said the federal agency had “reached out” to the university and “asked us to discontinue using the terms ‘briding study’ and ‘umbrella.'”
“We immediately updated the language to be consistent with their direction,” Kaler wrote.
A formal announcement of the change was not made to the public; the August 19 online news article by the university announcing the FDA approval does not contain an editor’s note.
Earlier this week, Burke appeared at a press conference at the university alongside Senator Dick Durbin, confirming the change in language and saying that, as a result, the university was seeking a new EUA.
“What we had said at the time, which was our understanding of the guidance at the time, is that we had completed a bridging study to an EUA, which at the time was exactly our understanding of the guidelines,” said Burke. “What’s being sought now, which is a really important step forward, is a new EUA specifically for this test to be used for asymptomatic testing.”
The UIUC campus has nearly 20 different testing centers with two lines apiece, each with the ability to collect 20,000 tests per day.
The UI is currently working with Illinois State University to set up a saliva-based testing site so that ISU can process COVID-19 tests on-campus.
That site is expected to open in November.