University of Illinois wins FDA approval for saliva COVID-19 test: ‘We’re wasting no time in deploying this,’ Gov. Pritzker vows

The saliva-based COVID-19 test developed by University of Illinois researchers has obtained federal emergency use authorization, a highly anticipated stamp of approval that confirms its accuracy and enables broader distribution across the state.

The test, known as covidSHIELD, appeared on the U.S. Food and Drug Administration’s online list of approved molecular diagnostic tests on Monday. U. of I. has relied on the test to keep its three campuses open for in-person learning since the fall, garnering national attention for the technology and running more than 1.5 million samples to date.

In a statement, Gov. J.B. Pritzker hailed the test as “groundbreaking work” and said he is “wasting no time in deploying this technology throughout the state.”

Pritzker has already allocated $20 million in federal relief funding to expand the saliva test to the state’s nine other public universities and 48 community colleges. The money will cover the purchase of 1 million tests to be divided among the campuses by the Illinois Board of Higher Education.

“Each university has determined how it will handle COVID-19 testing for the spring semester, as was the case during the fall, but SHIELD Illinois provides a proven option,” a news release said.

In its Feb. 24 approval letter, the FDA said it “considered the totality of scientific information available” and found the test to be an effective tool in diagnosing COVID-19. The test can detect small amounts of genetic material, including mutations of the SARS-CoV-2 virus that originated in other countries.

School systems, universities and companies have expressed interest in purchasing the tests, which require a small saliva sample from participants. The process is less invasive than the nose-swab method and can produce results within 24 hours.

Referring to the FDA decision, Bill Jackson, who leads international expansion efforts, said “this important step simplifies the process of setting up labs and gives our partners added assurance.”

Jay Walsh, the U of I System’s interim vice president for economic development and innovation, said he expects to resume conversations with local school districts, companies and other state entities that are interested in procuring tests.

“There is a huge need for accurate, fast and affordable testing to combat the pandemic, and we have invested in the ability to expand our covidSHIELD testing program beyond our campus communities — an investment that demonstrates the U of I’s commitment to the public good and to saving lives,” he said in a statement.

Some lawmakers previously grumbled at the timeline. U. of I. first unveiled the tests in August and applied for federal approval in December. The university erroneously believed it earned FDA approval in the summer but had to walk back those statements and officially apply for the designation.

echerney@chicagotribune.com

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