DiaSorin announces that it has received the Emergency Use Authorization (EUA) from the American Food and Drug Administration for the LIAISON SARS-CoV-2 S1 / S2 IgG test. This is the new serological test validated at the Policlinico San Matteo in Pavia, one of the national reference centers for the COVID-19 pandemic. The test identifies 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, of which 600 are currently present in the US hospital and commercial laboratories, the company announces . DiaSorin has also received funding to make the test available in the United States by the Biomedical Advanced Research and Development Authority (BARDA), the federal body of the American Department of Health, which is responsible for monitoring and identifying medical and diagnostic solutions to deal with health emergencies in the United States.
To quickly identify people who contracted the infectionAs well as those that have healed, tests that can be deployed on a large scale are immediately needed, said Gary Disbrow, Ph.D., BARDA Acting Director. The response provided by these tests is particularly important for healthcare professionals and workers in industries considered crucial, to allow for return to work after potential exposure to SARS-CoV-2. In response to the global pandemic and the health emergency, DiaSorin is increasing its production capacity of the LIAISON SARS-CoV-2 S1 / S2 IgG test in the Group’s main industrial site, located in Saluggia, Italy, to produce several million in the next months and distribute them all over the world.
Carlo Rosa, CEO of the DiaSorin Group, commented: FDA authorization for our serological test for COVID-19 for emergency use in the United States confirms the commitment and quality of the work done by our research team in finding solutions that can combat the world pandemic from Coronavirus. We believe that both our molecular and serological tests represent valuable and quality tools in the diagnostic decision-making process, once again positioning DiaSorin as the Diagnostic Specialist.
