CDC LOCS Lab Alert: FDA Revokes EUA for Curative SARS-CoV-2 Assay

On July 15, 2021, the U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) for the Curative SARS-CoV-2 Assay. Effective immediately, laboratories and testing sites should discontinue use of the Curative test.

In a letter to FDA dated June 16, 2021, Curative Inc. requested that the EUA for the Curative SARS-CoV-2 Assay be revoked effective July 15, 2021. The company stated that it was transitioning to the use of different EUA-authorized SARS-CoV-2 tests for the testing offered at its laboratories.

Refer to the FDA Letter of Revocation for more information.

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Online resources:

• Frequently Asked Questions about Coronavirus for Laboratories
• Clinical Laboratory COVID-19 Response Weekly Calls
• CDC Laboratory Outreach Communication System (LOCS)
• COVID-19 Information for Laboratories
• CDC COVID-19 website

This Lab Alert was originally published by the CDC Laboratory Outreach Communication System (LOCS).