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FDA Revises, Expands Yale SalivaDirect Emergency Use Authorization

NEW YORK – The Emergency Use Authorization of the SalivaDirect COVID-19 assay from the Yale School of Public Health's Department of Epidemiology of Microbial Diseases was revised and expanded earlier this week.

The US Food and Drug Administration will now permit authorized laboratories to use pre-assembled SalivaDirect Unsupervised Collection Kits for at-home sample collection from authorized distributors.

The EUA has also now been expanded to include four additional thermal cyclers.

These are the Thermo Fisher Scientific Applied Biosystems ViiA 7 Real-Time PCR System using QuantStudio Real Time PCR Software v1.3, the ABI QuantStudio 3 Real-Time PCR system using QuantStudio Design and Analysis Software v2.4.3, the Ubiquitome Liberty16 Pro system using Liberty16 App Version 1.8, and the Biomolecular Systems Mic instrument using Mic PCR software version 2.10.5.

The SalivaDirect assay was previously authorized for use with a number of other thermal cyclers: the CFX96 and CFX384 from Bio-Rad, the LightCycler 480 and Cobas Z480 from Roche, the CHAI Open PCR system, the Analytik Jena qTower, Ubiquitome Liberty16, and the AriaMx Real-Time PCR System from Agilent, and systems from Thermo Fisher Scientific including the ABI StepOne Real-Time PCR System, ABI 7500 Fast and Fast Dx, ABI Prism 7000, and the QuantStudio systems 5, 6, 7 Pro, 7 Flex, and 12K Flex.

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