Another wrinkle on EUA - favorable to ARYC since Arrayit is in the "two dozen" labs group.
The agency said it knows of about 160 serology tests being marketed in the United States that have not received authorization; of those, about two dozen are laboratory-developed tests that must be performed in special laboratories certified to do high-complexity testing. Those tests, many of which are being used at academic medical centers, won’t be required to have emergency-use authorizations, although the agency said it encourages it.
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