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NEW YORK – The US Food and Drug Administration issued new guidance Monday that refines its stance on serology testing during the COVID-19 pandemic, telling antibody test developers they will no longer be allowed to simply notify the agency, but instead must file for Emergency Use Authorization and meet certain performance thresholds.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.