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DiaSorin Molecular Gets CE Mark for Flu, RSV Assay

NEW YORK — DiaSorin Molecular said on Tuesday that it has received CE marking for its Simplexa Flu A/B & RSV Direct Gen II assay for influenza and respiratory syncytial virus (RSV).

The test is designed to run on DiaSorin Molecular's sample-to-answer Liason MDX real-time PCR instrument and can be used alone or in combination with the company's Simplexa COVID-19 Direct assay for SARS-CoV-2 infection, which received Emergency Use Authorization from the US Food and Drug Administration in March.

According to the Cypress, California-based company, influenza A, influenza B, RSV, and SARS-CoV-2 can have similar clinical presentations, and coinfection has been shown to cause increased severity of respiratory disease.

"We met our goal to have the Simplexa Flu A/B & RSV Direct Gen II assay available in time for use during the upcoming flu season and for patient samples to be tested, when needed, alongside the COVID-19 Direct assay," DiaSorin Molecular CSO Michelle Tabb said in a statement. "This flu season, the ability to detect and differentiate between influenza, RSV, and COVID-19 will be vital."

DiaSorin Molecular, a subsidiary of Italy's DiaSorin, said it has also submitted the Simplexa Flu A/B & RSV Direct Gen II assay to the FDA for 510(k) clearance.