The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

Today, the FDA issued a statement that it is actively working with our federal partners, international regulators and medical product companies to quickly address any potential impacts of the new omicron variant on the tools to fight the pandemic. The agency is working as quickly as possible to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics and vaccines. The FDA is closely monitoring the situation and is committed to communicating with the public as it learns more.

In a new project funded by the FDA, Embleema and George Washington University will conduct bioinformatic research and system development to expand the FDA-ARGOS database. FDA-ARGOS contains curated, quality-controlled genomic sequence data to support research and regulatory decisions. For example, researchers can use the FDA-ARGOS along with bioinformatics tools to validate the performance, sensitivity and specificity of diagnostic tests with computer modeling. Building on expansions during the COVID-19 pandemic, this project aims to further improve the utility of the FDA-ARGOS database as a key tool for medical countermeasure development and validation.