Thread by @EWoodhouse7, On August 19th, U of I announced its Shield T3 saliva-based COVID [...]

On August 19th, U of I announced its Shield T3 saliva-based COVID test had received an emergency use authorization (EUA) from the FDA, via a bridging study to Yale University's SalivaDirect, which was granted an EUA on Aug 15th. https://web.archive.org/web/20200819202954/https://blogs.illinois.edu/view/6367/1795135071

But this was not true. 1/*

Illinois rapid saliva test for COVID-19 now operating under FDA Emergency Use Authorization

The University of Illinois, Urbana-Champaign is now performing its new rapid, saliva-based COVID-19 test under the umbrella of an approved FDA Emergency Use Authorization.

https://web.archive.org/web/20200819202954/https://blogs.illinois.edu/view/6367/1795135071

On Sept 16, I emailed the FDA to ask about UofI's alleged EUA. FDA said there was no EUA, nor an app for an EUA. I also emailed the Yale researcher at the helm of SalivaDirect. He said UofI had not requested authorization from them, nor was aware of a bridging study 2/*

The FDA & Yale's responses contradict what the Governor, UofI president Tim Killeen, & UofI Chancellor Robert Jones each claimed at an Aug 19th press conference: That the Shield T3 test received an EUA. 3/* https://multimedia.illinois.gov/ioci_vid/Archive/2020/WebpageOnly/GOV/081920-COVID19Briefing/081920-COVID19Briefing.mp4

Marty Burke, a UofI chem prof, & co-dev of the saliva test, also spoke at the presser. His explanation is more complex, but still misleading & (far as I can tell) inaccurate. Interestingly, UofI established Shield T3 LLC on Aug 19th, the day of the presser. There's more... 3/*

Aug 19th was also the day the HHS issued a recession of guidelines for Lab-Developed Tests (LDTs). Could Burke be referring to that? If so, then why not invoke it? Why go thru the semantic gymnastics of the alleged bridge to Yale's FDA EUA? 4/* https://www.hhs.gov/coronavirus/testing/recission-guidances-informal-issuances-premarket-review-lab-tests/index.html

Rescission of Guidances and Other Informal Issuances

Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests

https://www.hhs.gov/coronavirus/testing/recission-guidances-informal-issuances-premarket-review-lab-tests/index.html

Also, as @Lucy26398575 has noted, being an LDT has nothing to do with Yale's EUA, and per the HHS's FAW, only applies to tests performed at the single campus CLIA lab, not to marketing the test beyond campus lab - which Shield T3 is doing. Actively. 5/* https://www.hhs.gov/sites/default/files/laboratory-developed-tests-faqs.pdf

Sen. Dick Durbin has invoked the non-existent EUA for Shield T3's saliva tests in letters to the Dept of Defense and HHS, respectively.The latter was signed by Durbin & a slew of other Illinois reps, including Sen. Duckworth 6/* https://www.durbin.senate.gov/newsroom/press-releases/durbin-urges-dod-to-adopt-wider-use-of-university-of-illinois-covid-19-saliva-based-testing-initiative

https://www.durbin.senate.gov/imo/media/doc/IL%20Letter_HHS-UI%20Testing%20Final%20Copy%20Signed.pdf

I emailed FDA & Yale on Sept 16th. Both said they would look into it

Sometime after Sept 18, U of I changed content on its website to remove the claim re: EUA. They now say they've "self-validated" the test. No mention of LDT. 7/* https://web.archive.org/web/20200911185730/https://covid19.illinois.edu/health-and-support/on-campus-covid-19-testing/
https://covid19.illinois.edu/health-and-support/on-campus-covid-19-testing/#howoften

U of I still says its "studies" (plural) to date show their test isn't inferior to nasal-swab tests. But where are these "studies"? I seeone pre-print, using 100 samples (ct 40)

Is this the "bridging study" the 8/19 press release & presser invoked? 8/* https://www.biorxiv.org/content/10.1101/2020.06.18.159434v1

In an interview with CNN, Martin Burke mentions "studies" conducted over the summer. Are the data from the studies available for review? Also said University was paying for the tests at $10/test. Whence that money? 9/* https://app.frame.io/reviews/2478039a-c895-41d4-a68b-106d8f9906a2/5cc04fb1-67a7-43f3-a98f-cd112c871451

If U of I is paying for the tests - out of whatever coffer - then why are they soliciting "donations" to fund a semester's worth of testing for a student? This money is being collected by the U of I Foundation. It then goes to Shield T3? How? 10/* https://with.illinois.edu/covid-19-relief-efforts/

U of I's "EUA" got a LOT of attention from Chicago & national press. (A few examples below.) Where was the fact-checking? 11/* https://www.mysuburbanlife.com/2020/08/19/fda-approves-university-of-illinois-new-covid-19-testing-method-using-saliva/as1pr58/
https://www.bloomberg.com/news/articles/2020-08-19/university-covid-19-saliva-test-could-be-gamechanger-pritzker
https://www.sciencemag.org/news/2020/08/new-drool-based-tests-are-replacing-dreaded-coronavirus-nasal-swab
https://cen.acs.org/analytical-chemistry/diagnostics/Saliva-tests-show-promise-widespread/98/web/2020/08

At the very least, the University, Governor, Senator Durbin et al need to issue retractions.

This is a serious breach of trust.

Who misled whom - & why? I'm not sure, but UofI stakeholders & IL taxpayers deserve an explanation--and and more discerning media. 12/*

And in a monumentally unethical move, U of I has changed its August 19th press release, without any note about the changes

Reminder that this is the school that's shaming & locking up tuition-paying students. Wow. 13/13 https://web.archive.org/web/20200819202954/https://blogs.illinois.edu/view/6367/1795135071

https://blogs.illinois.edu/view/6367/1795135071

And in a monumentally unethical move, U of I has changed its August 19th press release, without any note about the changes Reminder that this is the school that's shaming & locking up tuition-paying students. Wow. 13/13 https://web.archive.org/web/20200819202954/https://blogs.illinois.edu/view/6367/1795135071 https://blogs.illinois.edu/view/6367/1795135071

@threadreaderapp unroll

Latest Threads Unrolled: