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UIUC COVID-19 saliva test gains authorisation from US FDA

Updated: May 16, 2022

The saliva test already validated and deployed in New Zealand by Rako Science for asymptomatic COVID-19 screening has been approved for use in the United States by the US Federal Drug Administration (FDA).

The University of Illinois developed the SHIELD saliva test and, since July 2020, has been using it at their Urbana campus. They have conducted more than 1.4 million tests to date.

In a letter to Dr Joseph T. Walsch Jnr, University of Illinois the FDA state:

“FDA considered the totality of scientific information available in authorizing the emergency use of your product for the indication above. A summary of the performance information FDA relied upon is included in the EUA Summary (identified below). Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of your product, described in the Scope of Authorization of this letter (Section II), subject to the terms of this authorization.”

Rako Science licensed the SHIELD technology in September 2020 and collaborated with University of Illinois scientists to validate the test in New Zealand laboratories. The test was then accredited in December 2020 for asymptomatic screening in New Zealand. Rako is now providing the test to employers who want to do asymptomatic screening of their workforce.

“This is an exciting development for our colleagues at the University of Illinois. We want to congratulate them on all their hard work to get to this point,” Rako Science Director Dr Stephen Grice said.

“Rako’s science advisory board has been working hand in hand with the University of Illinois scientists. Rako was provided with paired samples from Illinois to run a double blinded study at Victoria University of Wellington and IGENZ in Auckland to validate and accredit the test in New Zealand. We are very grateful to the University of Illinois for their open collaboration with us.

“They have developed a highly accurate saliva test. The whole Rako Science team feels privileged to be working with them and to be able to deploy their technology to increase the protection available to New Zealanders.

“Rako Science’s saliva screening service is being deployed for high frequency, asymptomatic workplace testing. Rako has had constructive conversations with the Ministry of Health and they have advised they are satisfied with the scientific validation of our test.

“To Rako Science’s knowledge, the SHIELD test is the only saliva test that has been validated and accredited for asymptomatic COVID-19 screening in New Zealand,” Dr Grice said.

A link to the FDA’s accreditation can be found here.

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