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FDA Clears DiaSorin Test for Influenza, RSV

NEW YORK – DiaSorin Molecular announced on Tuesday the US Food and Drug Administration has cleared the company's Simplexa Flu A/B and RSV Direct Gen II kit.

The test can be run alone or with the Simplexa COVID-19 Direct kit for the differential diagnosis of SARS-CoV-2, influenza A/B, and respiratory syncytial virus, the Cypress, California-based company said. The Simplexa COVID-19 Direct kit received Emergency Use Authorization from the FDA in March.

With the upcoming flu season occurring amid the coronavirus pandemic, being able to differentiate the viruses, which have similar clinical presentations, "can have major implications for the management of therapeutic regimens, infection control, and community mitigation efforts," DiaSorin Molecular said in a statement.

The Simplexa Flu A/B and RSV assay was designed to be used with DiaSorin's Liaison MDx instrument.

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