DiaSorin’s LIAISON SARS-CoV-2 S1/S2 IgG Test Receives FDA Emergency Use Authorization

DiaSorin (Saluggia, Italy) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration for its 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 US. DiaSorin recently signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services to obtain funding aimed at making the test available in the US.

DiaSorin’s LIAISON SARS-CoV-2 S1/S2 IgG test will respond to the need to identify the presence of antibodies in people who have been infected with SARS-CoV-2 and will be available on the 5,000 LIAISON XL platforms installed worldwide, of which 600 are currently installed in US hospital and commercial laboratories. 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 new serological test was validated at Policlinico San Matteo in Pavia, a major Italian reference center for the COVID-19 pandemic. DiaSorin is currently scaling up its production capacity in its main facility based in Saluggia, Italy, in order to manufacture several million tests of the LIAISON SARS-CoV-2 assay over the next months, distributing the test worldwide and responding to the global pandemic and public health emergency.

"The authorization of our serology test against COVID-19 in the US confirms the commitment and quality of the job done by our research team in finding solutions to fight the worldwide Coronavirus pandemic," said Carlo Rosa, CEO of the DiaSorin Group. "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."

"Widely distributed tests are needed immediately to quickly identify not only people who have an active infection but also those who have recovered," said BARDA Acting Director Gary Disbrow, Ph.D. "This knowledge is particularly important for healthcare providers and other critical infrastructure personnel, to return to work after any potential exposure to SARS-CoV-2."