Confirms the launch of a fully automated serology test to detect antibodies against SARS-CoV-2 in COVID-19 patients by the end of April 2020, allowing identification of immune response development to the virus
DiaSorin (FTSE MIB: DIA) announced today the completion of the studies conducted at the Policlinico San Matteo in Pavia to support the launch of a new serological and high-processing volume test to detect the presence of antibodies in patients infected with the SARS-CoV-2.
The Company is working to obtain the CE mark and the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) by the end of April, 2020.
The new serological test is designed to recognize IgG antibodies directed against the S1 and S2 domains of the SARS-CoV-2 virus spike protein, selected for its ability to provide specificity for SARS-CoV-2 compared to other Coronaviruses. The product has been designed to respond to the need to identify people in the population who have already been infected with the virus, where diagnosis has not been performed with a swab and a molecular diagnostic test.
The test can be performed on the LIAISON® XL platform, which allows fully automated management of the diagnostic process, allowing laboratories to process up to 170 patient sera samples per hour, with a minimum level of intervention required by laboratory operators.
The current install base of LIAISON® XL platforms, approximately 5,000 units worldwide, of which more than 500 in Italy and a similar number in the United States, boasts a widespread geographical presence in primary hospital institutions and commercial laboratories.
The LIAISON® SARS-CoV-2 IgG kit will be made available in the next few days for clinical research and evaluation and will be launched in Europe CE marked and submitted to the FDA under the Emergency Use Authorization process in the following weeks.