The US Food and Drug Administration (FDA) has granted 510(k) clearance for DiaSorin’s Simplexa COVID-19 Direct kit.

The Simplexa COVID-19 Direct kit has been designed for detecting the SARS-CoV-2 virus directly from nasopharyngeal or nasal swab samples.

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It is developed for use on the LIAISON MDX platform and can run directly through the direct amplification disc (DAD).

The Covid-19 molecular assay targets the ORF1 ab and S gene regions of the SARS-CoV-2 genome to reduce the impact of mutations on the performance of the kit on the virus as well as potential variants of concern.

It does not require sample pre-treatment and provides results in just over an hour.

This allows prompt decisions regarding the treatment and isolation of infected patients to be made.

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DiaSorin stated that the test kit can be used by hospitals or commercial labs and that it enables timely testing with accurate results.

DiaSorin subsidiary Luminex President Angelo Rago said: “The FDA 510(k) clearance of our Covid-19 test demonstrates our commitment to commercialise products featuring the highest standards of diagnostic testing against Covid-19 and other respiratory pathogens.

“The Simplexa COVID-19 Direct Kit will provide a higher level of confidence, enabling clinicians to make effective diagnostic decisions with rapid and accurate results.”

DiaSorin’s Covid-19 molecular diagnostic products suite includes the Simplexa SARS-CoV-2 Variants Direct (RUO) and the Simplexa COVID-19 & Flu A/B Direct assay.

The company has also submitted an application to the FDA to review the Simplexa COVID-19 & Flu A/B Direct assay for differential diagnosis.

Last July, DiaSorin completed the purchase of Luminex for an equity value of nearly $1.8bn, or $37 per share.

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