07/18/2021: Lab Alert: FDA Revokes EUA for Curative SARS-CoV-2 Assay

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Individuals Performing COVID-19 Testing

Level: Laboratory Alert

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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The Laboratory Outreach Communication System

Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: July 19, 2021