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September 14, 2022

US FDA grants 510(k) clearance for DiaSorin’s Covid-19 Direct kit

The Simplexa COVID-19 Direct kit targets the ORF1 ab and S gene regions of the SARS-CoV-2 genome.

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.

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.

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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