University of Illinois’ COVID-19 saliva test moves closer to FDA approval, but not fast enough to meet the demand: ‘Every school district in Illinois would love to have this’
The University of Illinois has completed a critical step toward obtaining federal approval for its saliva-based COVID-19 test, but some lawmakers worry it’s taking too long to help other state colleges, school districts and companies struggling to operate amid the pandemic.
The test, developed by faculty at the state’s largest public university, was validated in a clinical study and last week submitted to regulators for emergency use authorization, a designation that enables broader distribution, according to Jay Walsh, interim vice president for economic development and innovation at the U. of I. System.
“We’re working as hard and as fast as we can on this,” Walsh said Thursday. “There are numerous challenges on rolling this out. We’ve tackled a lot of them on campus. … We hope to be able to leverage that learning and move this quickly forward.”
But nearly six months after its unveiling, the test remains largely confined to the school’s campuses in Urbana-Champaign, Chicago and Springfield. With an emergency use request submitted, other parties will be able to use the test while the U.S. Food and Drug Administration reviews the application. It’s unclear how long that will take, but the emergency authorization is desirable because it provides liability protection among other regulatory benefits.
Public and private universities in Illinois will be among the first to deploy the tests this month, though some might opt to wait until federal approval is granted, officials said. About $20 million in federal stimulus funds will be used to purchase 1 million tests for the state’s 12 public universities, according to U. of I. spokesman Ben Taylor.
If universities need more, they can buy tests for $20, and additional subsidies might be made available, Taylor said. The tests are also being sold to public school districts for $20 each, to some private universities for $25 and to companies for $30. Prices vary for customers out of state. An effort dubbed “Shield Illinois” is responsible for implementing the test statewide.
The need remains urgent, as the state’s COVID-19 case positivity rate is again on the upswing. It reached 8.6% for the week ending Sunday, the highest since mid-December. State health officials on Monday reported 5,059 confirmed and probable cases of COVID-19, bringing the seven-day average of new daily cases to 6,074 — the first time the average has topped 6,000 since Dec. 25.
Amid persistently high numbers, some lawmakers have questioned the pace of progress of the saliva test rollout.
At a recent Illinois Senate hearing of the Higher Education Committee, members pressed for a timeline of when the test would be expanded to other institutions. The tests, which provide results in about 24 hours, cost less and are easier to perform than the more ubiquitous nasal swab method.
“I’ve got 50 school districts’ worth of kids that would love to have this available to them,” Sen. Chapin Rose, R-Mahomet, said during the Dec. 14 hearing. “I’m sure every school district in Illinois would love to have this. … The thing works. Why the hell don’t we have it on the streets?”
Other lawmakers, including Sen. Pat McGuire, D-Joliet, stressed the urgency of providing the test to the state’s public universities so that more in-person learning can resume.
He also worried that Illinois residents were not being prioritized to receive the test, though it’s the product of taxpayer dollars, asking if it would be utilized by out-of-state colleges before Illinois public universities.
Indeed, the test is being sold across state lines and internationally through a separate venture called Shield T3, a university-related organization overseen by the U. of I. board of trustees.
The University of Wisconsin-Madison agreed to conduct 15,000 saliva tests per week, with each test costing $25, according to a contract obtained by the Tribune in a public records request. The school put down a $1 million deposit to reserve the necessary equipment, according to the contract.
And in California, the tests are already in use by Bloom Energy, a company in Silicon Valley that contracted for services. In a news release, Shield T3 said the tests were launched in a mobile lab at the company’s Sunnyvale facility Dec. 14.
Bill Jackson, principal officer of Shield T3, said the company agreed to run the tests prior to the emergency use designation, an option not all clients are willing to pursue.
U. of I. researchers have also shared their methodology with other universities, including the University of Notre Dame, which have been able to replicate the process and conduct saliva tests on their own.
In response to concerns aired at the hearing, U. of I. System President Tim Killeen defended the lengthy process to obtain federal approval and ramp up testing locally.
“This is not something you can turn on overnight,” Killeen said. “There’s logistics, there’s supply chain, there’s a lot of complexity. … It’s not like we could have rushed through this at some faster pace.”
To date, the university has conducted more than 1 million saliva tests for students, faculty and staff at the school’s campuses while fine-tuning the protocols, Killeen said. The test helped the schools provide in-person classes for thousands of students this fall.
In that undertaking, students using Urbana-Champaign facilities were required to submit saliva samples up to three times per week. A lab on campus analyzed the saliva and turned around results in about 24 hours, allowing the school to quickly identify cases, isolate infections and initiate contact tracing. Participants provided saliva by drooling into small vials.
More than $20 million went into developing the test and purchasing equipment to set up labs across the state, Taylor said.
Loyola University Chicago plans to use the test when students return for spring classes and will pay $20 per test for a minimum 5,000 tests this semester, according to a contract obtained by the Tribune in a public records request. The school plans to administer “anywhere between 10,000 to 15,000 tests per week for the spring semester,” said spokeswoman Anna Rozenich.
The FDA informed the university in September that such statements, shared in a news briefing and on the U. of I. website, did “not appropriately represent the status of your test and which may be contributing to the misunderstandings regarding your test.”
The university, however, blamed the FDA for confusing protocols. The school erroneously thought it obtained approval by comparing its test to one developed at Yale University, which had been granted emergency use authorization.
In the months that followed, U. of I. worked to conduct a clinical study for its test, which ended in December and involved 120 people, according to Walsh. Results showed the saliva tests were accurate when compared with nasal swabs from the same individuals, he said.
Ron Watkins, an associate dean in the business school leading Shield Illinois, said the test is being sold at the cost of production, which is well below that of comparable molecular tests.
Three of the state’s public universities have finalized agreements to use the tests next semester, while others are either in the process of doing so or considering other options, according to U. of I. officials.
Testing at the three schools on board — Illinois State University, Eastern Illinois University and Northern Illinois University — is expected to begin in January or February, Watkins said.
Chicago State and Governors State universities are in the process of contracting services, Watkins said. The first batches of tests will be processed at a lab in Decatur, one of seven that Watkins and his team are setting up across the state, until more proximate ones are operational.
Northeastern Illinois University is still evaluating the costs and personnel resources needed to provide saliva testing, according to spokesman Michael Hines. NEIU hasn’t contracted with Shield Illinois and saw only 15 positive cases on campus this fall when 90% of classes were remote or online, Hines said.
The Southern Illinois University campuses in Carbondale and Edwardsville are opting for different testing vendors.
With the approvals and plans that need to be in place, timing was a factor that led SIUE to go with another provider, said spokesman Doug McIlhagga.
“We needed to have an FDA approved test ready to go Nov. 11 for SIUE to be successful,” he said in an email. “Not knowing what the future might bring, we will evaluate our testing process in March and reevaluate our options at that time.”
Illinois State University, which approved a contract of up to $5.5 million with Shield Illinois this semester, is eager to use the U. of I. test but does not expect it will be ready by the time students return next Monday. As a result, ISU procured another vendor to provide rapid antigen testing beginning Monday, said spokesman Eric Jome.
“We’re waiting for the actual FDA approval,” Jome said. “We don’t want to get out ahead of something that’s not gone through the approval process, so generally we are looking at the approval as the marker.”