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FDA Grants EUA, CE Mark For BD's Combination Molecular Diagnostic To Detect SARS-CoV-2

Medical technology company Becton, Dickinson and Co. or BD (BDX)announced Friday that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a new molecular diagnostic test for both SARS-CoV-2, including variants from the U.K. and South Africa, and Influenza A+B that can return results in two to three hours. The new test also has been CE marked to the IVD Directive (98/79/EC).

A computer analysis showed that 99.9% of the genetic sequences of these variants are an identical match to at least one of the two molecular targets for the tests. This ability to detect these new variants also applies to the standalone SARS-CoV-2 test for the BD MAX System.

The BD SARS-CoV-2/Flu assay is run on the BD MAX System and distinguishes between SARS-CoV-2 and Influenza A+B, providing a positive or negative result for each virus using a single specimen.

The BD MAX System, a molecular diagnostic platform, is already in use at thousands of laboratories worldwide, and each unit is capable of analyzing hundreds of samples over a 24-hour period.

The BD SARS-CoV-2/Flu for BD MAX System kits are now available for order in the United States and Europe.

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