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DiaSorin Molecular Receives CE Mark for Multiplex COVID-19, Influenza Test

NEW YORK – DiaSorin Molecular announced on Monday that its Simplexa COVID-19 & Flu A/B Direct test has received CE marking.

The multiplex test is designed for use on the Liaison MDX instrument and differentiates between SARS-CoV-2 and influenza A/B nucleic acids from one sample in one reaction well.

It was validated with more than 80 strains of influenza, as well as emerging SARS-CoV-2 variants, said Cypress, California-based DiaSorin Molecular, which is part of Saluggia, Italy-based DiaSorin Group.

The test is run directly from nasopharyngeal swabs without needing off-board extraction and will be submitted to the US Food and Drug Administration for 510(k) review, the firm said.

DiaSorin received Emergency Use Authorization from the FDA in March 2020 for its Simplexa COVID-19 Direct test and FDA clearance for its Simplexa Flu A/B and RSV Direct Gen II kit in September 2020, which can be used with the COVID-19 test.