FDA issues EUA for LabCorp coronavirus test

2019 05 02 23 38 2538 Check Mark 400

The U.S. Food and Drug Administration (FDA) on March 16 issued an emergency use authorization (EUA) to LabCorp for the company's coronavirus testing kit.

The authorization covers LabCorp's COVID-19 reverse transcription polymerase chain reaction (RT-PCR) test. On the same day, the FDA gave Hologic authorization for its Panther Fusion SARS-CoV-2 assay.

Since the beginning of the outbreak of the coronavirus, more than 90 test developers have been in contact with the FDA, and more than 40 labs have informed the agency that they are testing or intend to begin testing soon, said FDA Commissioner Dr. Stephen Hahn in a statement.

"Staff at FDA have been working nonstop to expedite the review and authorization of diagnostics during this public health emergency. ... We stand ready to continue to support medical products in the pipeline to fight this virus," he said.

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