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Becton, Dickinson's COVID-19/Influenza Combo Molecular Assay Wins FDA Emergency Use Nod

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Vandana Singh
·1 min read
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  • The FDA has granted Emergency Use Authorization (EUA) to Becton Dickinson and Co's (NYSE: BDX) new molecular test for both SARS-CoV-2 and Influenza A+B. The new test has also received a CE mark in Europe.

  • The new EUA includes updated information in the test's instructions for use in diagnosing variants of the SARS-COV-2 virus, including variants from the U.K. and South Africa. This ability to detect these new variants also applies to the standalone SARS-CoV-2 test for the BD MAX System.

  • The assay runs on an automated BD MAX System that can process 24 samples and return results in two to three hours. The test distinguishes between SARS-CoV-2 and Influenza A+B, providing a positive or negative result for each virus using a single specimen.

  • The test is the latest addition to the company's COVID-19 diagnostics response. In October last year, BD announced the CE mark for the VIASURE SARS-CoV-2 PCR detection kit, which can run a single module that tests COVID-19 and Influenza and Respiratory Syncytial Virus concurrently.

  • Price Action: BDX shares closed 0.2% higher at $253.39 on Thursday.

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