Simplexa COVID-19, flu A/B assay gets CE mark

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November 2021—DiaSorin Molecular announced that it has CE marked its Simplexa COVID-19 and Flu A/B Direct kit. The multiplex test allows for the in vitro qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B from a patient sample in one reaction well. The assay is designed for use on the Liaison MDX and is run directly from nasopharyngeal swabs without the need for off-board extraction.

The company plans to submit the kit to the FDA for 510(k) review.