EUA for COVID-19 Prognostics

KatieQA

Starting to get Involved
#1
Does anyone know if Emergency Use Authorization from the FDA for COVID-19 can be applied to prognostics in addition to the detection of SARS-CoV-2? For example, diagnostics related to IL-6 or other inflammatory markers indicative of progression of disease state?
 
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indubioush

Quite Involved in Discussions
#2
My humble guess is that a device that is considered an "aid to diagnosis" would not be able to obtain the EUA if there are other devices on the market that do the same thing.
 
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