DiaSorin S p A : LIAISON SARS-CoV-2 IgM test receives FDA Emergency Use Authorization for the U.S. market

DIASORIN'S LIAISON® SARS-CoV-2IgM TEST RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR THE U.S. MARKET

• A fully automated serology kit to identify the immediate response to SARS-CoV-2 in COVID-19 patients
• Available on LIAISON® XL platform
• The fourth diagnostic solution available in the U.S. to help healthcare systems fight COVID-19

Saluggia - October 1, 2020 - DiaSorin (FTSE MIB: DIA) announced today that it has received U.S. FDA Emergency Use Authorization (EUA) for its LIAISON® SARS-CoV-2 IgM test.

The LIAISON® SARS-CoV-2 IgM test will be available on the LIAISON® XL platforms installed in the U.S. market, using chemiluminescence immunoassay (CLIA) technology for the qualitative determination of specific IgM antibodies to SARS-CoV-2 in human serum or plasma samples.

The test identifies the presence of IgM antibodies in patients who have been infected with SARS-CoV- 2, enabling the distinction between newly infected and past-infected patients.

The LIAISON® SARS-CoV-2 IgM test is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2 and as a tool to analyze the immune response of infected patients. Moreover, COVID-19 early detection through IgM response is key in patient management and population monitoring programs.

"This is the fourth product made available in the U.S. by DiaSorin. to support the management of the pandemic. It will be part of our U.S. panel for COVID-19 testing, in addition to our serology IgG test and to our molecular diagnostic kits for COVID-19 detection and for the differentiation between SARS- CoV-2 and Flu A, B and RSV" commented Chen Even, Chief Commercial Officer of the DiaSorin Group.

"The United States have been our main market for several years. Since the beginning of the pandemic we have continued to invest in R&D to make our products available to all the U.S. hospitals that have been using our technologies for over thirty years", commented Carlo Rosa, CEO of the DiaSorin Group.

For additional information, please contact:
Riccardo Fava	Emanuela Salvini
Corporate Vice President Communication & Investor Relations	Investor Relator
Tel: [phone]	Tel: [phone]
[e-mail]	[e-mail]

DiaSorin

Headquartered in Italy and listed at the Italian Stock Exchange in the FTSE MIB Index, DiaSorin is a global leader in the In Vitro Diagnostic (IVD) field, with 26 companies, 4 branches, 5 manufacturing facilities and 5 research and development centers.

For over 50 years, the Company has been developing, producing and marketing reagent kits used by diagnostic laboratories worldwide.

The extensive diagnostic testing offer, made available through continuous investments in research, positions DiaSorin as the player with the broadest range of specialty tests available within the diagnostic market, and identifies the Group as the "Diagnostic Specialist".

More info atwww.diasoringroup.com