Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection | FDA

Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection | FDA

FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests

This week, the U.S. Food and Drug Administration (FDA) further supported its effort to evaluate diagnostic tests for COVID-19, by providing a SARS-CoV-2 reference panel. The panel is an independent performance validation step for molecular diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes.  The FDA panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process or whose tests have been issued an EUA. The FDA will provide the reference panel to developers at the appropriate stage in the process. There is no need for these test developers to take additional action in order to receive the reference panel.

Read the Press Release Questions? Email CDRH-EUA-Templates@fda.hhs.gov.