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DiaSorin Gets FDA 510(k) for Molecular COVID-19/Flu Assay

NEW YORK – DiaSorin said late Friday that it has nabbed US Food and Drug Administration 510(k) clearance for a molecular assay that differentiates between infections with the SARS-CoV-2 and influenza A and B viruses.

The Saluggia, Italy-based firm said it received the green light from the agency for its multiplex Simplexa COVID-19 & Flu A/B Direct assay. The real-time RT-PCR assay is designed for use on the Liaison MDX instrument, and it delivers results in little more than one hour.

The firm said up to eight samples can be tested at one time in a streamlined, simple workflow that doesn’t require sample extraction and involves minimal hands-on time.

DiaSorin secured CE marking for the assay in September 2021. The firm's Cypress, California-based DiaSorin Molecular division said at the time the assay had been validated with more than 80 strains of influenza and emerging SARS-CoV-2 variants.

Angelo Rago, president of DiaSorin's Luminex subsidiary, said in a statement that, "By pairing flu and COVID-19 testing in one easy-to-use, rapid molecular assay, we hope to ease the burden on clinical labs that would otherwise have to run multiple tests for each patient to get complete answers."

The firm noted that the test development had been funded at least in part by the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority.

DiaSorin received US FDA Emergency Use Authorization in March 2020 for its Simplexa COVID-19 Direct test and clearance in September 2020 for its Simplexa Flu A/B and RSV Direct Gen II kit.