Latest news on DiaSorin's response to COVID-19 outbreak
April 24, DiaSorin obtains Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for the LIAISON® SARS-CoV-2 S1/S2 IgG test.
The product is one of the first high-throughput assays based on the CLIA (Chemiluminescent ImmunoAssay) technology to receive EUA in the U.S.
The new serological test was validated at Policlinico San Matteo in Pavia, a major Italian hospital and among the national reference centers for the COVID-19 pandemic.
The test will respond to the need to identify the presence of antibodies in patients who have been infected with SARS-CoV-2 and will be available on the 5,000 LIAISON® XL platforms installed worldwide. With a throughput of 170 patient samples per hour, the LIAISON® XL platform will support an increase in testing capacity and the availability of diagnostic testing in order to mitigate the potential impact of this virus.
The test was previously CE Marked on April 17, 2020.
March 20, DiaSorin Molecular LLC, a division of DiaSorin S.p.A., announced it has received Emergency Use Authorization (EUA) from the FDA for the Simplexa™ COVID-19 Direct kit, the innovative molecular diagnostic test designed for use on the LIAISON MDX platform, for the rapid detection of the new Coronavirus COVID-19
The Simplexa COVID-19 Direct kit is designed for use on the LIAISON® MDX and can be utilized by hospital laboratories without the need to send the sample out, allowing for timely testing and results. The kit contains an all-in-one reagent mix, which is ready to use. Only one instrument and one reagent are required to perform the test. It bypasses the need for traditional extraction procedures, enabling rapid detection in a little over an hour which is significantly faster than the up to seven hours currently required by traditional extraction followed by amplification technologies, ultimately allowing prompt decision making regarding isolation of infected patients.
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Carlo Rosa, CEO DiaSorin
"The authorization of our serology test against COVID-19 in the U.S. confirms the commitment and quality of the job done by our research team in finding solutions to fight the worldwide Coronavirus pandemic. We believe that both our molecular and serology tests represent valuable and qualitative tools in diagnostics decision-making, positioning once again DiaSorin as the Diagnostic Specialist".
The fully automated serology test for the detection of SARS-CoV-2 IgG Antibodies
Video clip for media
INTERVIEW WITH CARLO ROSA, DIASORIN GROUP CEO
Quarto Grado, Rete 4, 27 March 2020
INTERVIEW WITH CARLO ROSA, CEO OF DIASORIN GROUP
DiaSorin's response to COVID-19
CNBC Class, 19 March 2020
THE TRUMP ADMINISTRATION AWARDS DIASORIN TO DEVELOP RAPID COVID-19 TESTS FOR THE NEW CORONAVIRUS WITHIN ONE HOUR
A RAPID RESPONSE MOLECULAR DIAGNOSTIC TEST FOR THE CURRENT NOVEL CORONAVIRUS (COVID-19)
Diasorin Group has officially announced it has completed the studies for the launch of a newly effective molecular diagnostic test for COVID-19, that has been developed by the DiaSorin Research Center in Gerenzano, near Milan.