www.fdanews.com/articles/198694-fda-revises-its-policy-on-multi-analyte-covid-19-euas
FDA Revises Its Policy on Multi-Analyte COVID-19 EUAs
August 25, 2020
The FDA has updated its policy on COVID-19 testing, clarifying that manufacturers of multi-analyte respiratory panels which include SARS-CoV-2 are now eligible for Emergency Use Authorization (EUA).
The agency noted that multi-analyte panels are useful when multiple respiratory pathogens are circulating at the same time, as is expected with the upcoming flu season.
When determining whether to issue an EUA for a multi-analyte respiratory panel that includes SARS-CoV-2, the agency said it considers the clearance or approval status of diagnostics for the other analytes on the panel.