FDA Clears Two More Coronavirus Diagnostics for Emergency Use

March 17, 2020

The FDA has granted emergency use authorization to Hologic’s Panther Fusion SARS-CoV-2 assay and LabCorp’s coronavirus RT-PCR test, expanding diagnostic capabilities for the coronavirus outbreak.

FDA Commissioner Stephen Hahn said that agency is  working nonstop to expedite the review and authorization of diagnostics during the public health emergency.

So far, more than 90 diagnostic developers have contacted the FDA seeking guidance on coronavirus test development and validation, the agency said.

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