Autobio Diagnostics EUA for Anti-SARS-CoV-2 Test Revoked by FDA

Autobio Diagnostics had the Emergency Use Authorization for its Anti-SARS-CoV-2 Rapid Test revoked by the U.S. Food & Drug Administration.

• “The Agency has concluded that it is unlikely that this test is effective in detecting SARS-COV-2 IgM antibodies and that the known and potential benefits of its use do not outweigh the known and potential risks,” the FDA said in a letter dated Aug. 6
• The EUA was issued on April 24

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