GENOA (Pakistan Point News / Sputnik - 07th April, 2020) DiaSorin, an Italian biotechnology company specializing in immunodiagnostics and molecular diagnostics, said on Tuesday that it had concluded all studies related to its new testing system for identifying coronavirus-immune people and seeks to make it available on the market before the end of April.
"DiaSorin ... announced today the completion of the studies conducted at the Policlinico San Matteo in Pavia to support the launch of a new serological and highprocessing volume test to detect the presence of antibodies in patients infected with the SARS-CoV-2 [virus that caused COVID-19]," the statement read.
The company added that it was working to obtain the European Economic Area certification mark (CE) and the emergency use authorization by the US food and Drug Administration before the end of April 2020, the statement added.
The tests are therefore only going to be available on the European market after receiving the CE certification and on the US market after the approval of the Food and Drug Administration.
This test was designed to find people who had already contracted COVID-19 but experienced no symptoms, and were not diagnosed because they never took the regular test. It will be processed by LIAISON XL, a platform that analyzes up to 170 patient serum samples every hour with minimal intervention from the laboratory workers.
"The alarm generated by the Coronavirus pandemic prompted us initially to work on a molecular diagnostic solution that we were able to offer to hospital laboratories very quickly. At the same time, we started to work on an immunodiagnostic test to respond to the increasing need to conduct epidemiological investigations to establish the percentage of the population exposed to the virus in the absence of a diagnosis performed with molecular tests on a swab," Fabrizio Bonelli, the chief scientific officer of DiaSorin, said in the press statement.
Italy has reported 135,586 COVID-19 cases in total up to now, including 17,127 deaths, the highest number of any country. However, the rate of new patients and new deaths has been declining over the past days.
