FDA Revokes Five Authorizations for COVID-19 Diagnostics

The rush to develop COVID-19 tests appears to be slowing down. In an April 18 notice, the FDA said it had revoked Emergency Use Authorizations (EUAs) for five COVID-19 diagnostic tests at the manufacturers’ own requests last month.

The agency said it had revoked the EUAs during March for five devices:  DiaSorin’s Liaison SARS-CoV-2 IgM assay, Centogene’s CentoFast-SARS-CoV-2 real-time polymerase chain-reaction (RT-PCR) assay, CentoSure’s SARS-CoV-2 RT-PCR assay, RTA’s Diagnovital SARS-CoV-2 RT-PCR kit and BillionToOne’s qSanger-COVID-19 assay.

The companies all said they no longer needed the emergency authorization because they were not distributing the tests.