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& #39;s SalivaDirect, which was granted an EUA on Aug 15th. https://web.archive.org/web/20200819202954/https://blogs.illinois.edu/view/6367/1795135071

But">https://web.archive.org/web/20200... 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& #39;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& #39;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">https://multimedia.illinois.gov/ioci_vid/...

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& #39;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& #39;s FDA EUA? 4/* https://www.hhs.gov/coronavirus/testing/recission-guidances-informal-issuances-premarket-review-lab-tests/index.html">https://www.hhs.gov/coronavir...

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& #39;s EUA, and per the HHS& #39;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">https://www.hhs.gov/sites/def...

Sen. Dick Durbin has invoked the non-existent EUA for Shield T3& #39;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/newsroom/...

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

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& #39;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://web.archive.org/web/20200... href=" #howoften">https://covid19.illinois.edu/health-and-support/on-campus-covid-19-testing/ #howoften">https://covid19.illinois.edu/health-an...

https://covid19.illinois.edu/health-an..." title="I emailed FDA & Yale on Sept 16th. Both said they would look into itSometime after Sept 18, U of I changed content on its website to remove the claim re: EUA. They now say they& #39;ve "self-validated" the test. No mention of LDT. 7/* https://web.archive.org/web/20200... href=" https://covid19.illinois.edu/health-and-support/on-campus-covid-19-testing/ #howoften">https://covid19.illinois.edu/health-an...">

U of I still says its "studies" (plural) to date show their test isn& #39;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">https://www.biorxiv.org/content/1...

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">https://app.frame.io/reviews/2...

If U of I is paying for the tests - out of whatever coffer - then why are they soliciting "donations" to fund a semester& #39;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/">https://with.illinois.edu/covid-19-...

U of I& #39;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.mysuburbanlife.com/2020/08/1...
https://www.bloomberg.com/news/articles/2020-08-19/university-covid-19-saliva-test-could-be-gamechanger-pritzker">https://www.bloomberg.com/news/arti...
https://www.sciencemag.org/news/2020/08/new-drool-based-tests-are-replacing-dreaded-coronavirus-nasal-swab">https://www.sciencemag.org/news/2020...
https://cen.acs.org/analytical-chemistry/diagnostics/Saliva-tests-show-promise-widespread/98/web/2020/08">https://cen.acs.org/analytica...

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& #39;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

https://abs.twimg.com/emoji/v2/... draggable="false" alt="🚩" title="Dreieckige Fahne an einem Pfosten" aria-label="Emoji: Dreieckige Fahne an einem Pfosten">

Reminder that this is the school that& #39;s shaming & locking up tuition-paying students. Wow. 13/13 https://web.archive.org/web/20200819202954/https://blogs.illinois.edu/view/6367/1795135071">https://web.archive.org/web/20200...

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

And in a monumentally unethical move, U of I has changed its August 19th press release, without any note about the changeshttps://abs.twimg.com/emoji/v2/... draggable=

Reminder that this is the school that& #39;s shaming & locking up tuition-paying students. Wow. 13/13 https://web.archive.org/web/20200... https://blogs.illinois.edu/view/6367..." title="And in a monumentally unethical move, U of I has changed its August 19th press release, without any note about the changeshttps://abs.twimg.com/emoji/v2/... draggable="false" alt="🚩" title="Dreieckige Fahne an einem Pfosten" aria-label="Emoji: Dreieckige Fahne an einem Pfosten"> Reminder that this is the school that& #39;s shaming & locking up tuition-paying students. Wow. 13/13 https://web.archive.org/web/20200... https://blogs.illinois.edu/view/6367...">

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