Diasorin — Regulatory Filings 2020

May 18, 2020

Informazione Regolamentata n. 0957-38-2020		Data/Ora Ricezione 18 Maggio 2020 11:25:41	MTA
Societa'	:	DiaSorin
Identificativo Informazione Regolamentata	:	132643
Nome utilizzatore	:	DIASORINN01 - Fava
Tipologia	:	REGEM
Data/Ora Ricezione	:	18 Maggio 2020 11:25:41
Data/Ora Inizio Diffusione presunta	:	18 Maggio 2020 11:25:42
Oggetto	:	S1S2 IGG TEST IS THE FIRST TO RECEIVE THE APPROVAL FROM HEALTH CANADA	DIASORIN - THE LIAISON® SARS-COV-2
Testo del comunicato

Vedi allegato.

THE LIAISON® SARS-COV-2 S1/S2 IGG TEST IS THE FIRST TO RECEIVE THE APPROVAL FROM HEALTH CANADA

Saluggia - May 18, 2020 - DiaSorin (FTSE MIB: DIA) is announcing today that it has obtained approval for its LIAISON® SARS-CoV-2 S1/S2 IgG test from Health Canada, the Canadian government department responsible for federal health policy. Approval was officially awarded on May 12, 2020 and Health Canada officials acknowledged that the DiaSorin test is the first serological test to receive authorization in the country.

The DiaSorin test will assist with the completion of a National screening study involving more than1 million serological samples over the next 2 years in Canada, tracking the impact of the virus on the population, especially on the categories most at risk, such as health care workers and the elderly.

The LIAISON® SARS-CoV-2 S1/S2 IgG test was conceived and developed by the DiaSorin Italian research center in Gerenzano (Italy) and guarantees extremely accurate results, with a sensitivity of 97.4% and a specificity of 98.5%. The test was CE marked on April 17, 2020 and received the Emergency Use Authorization (EUA) by the American Food and Drug Administration on 25 April for the U.S. territory.

The test identifies the presence of antibodies in patients who have been infected with SARS-CoV-2 and is available on over 5,000 LIAISON® XL platforms, installed worldwide. With a throughput of 170 patient samples per hour, the LIAISON® XL platform will support an increase in testing capacity in order to mitigate the potential impact of this virus.

DiaSorin is currently scaling up its production capacity in its main facility based in Saluggia (Italy), 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.

"I am proud that Health Canada has approved our serological test for COVID-19 as the first available to initiate such a relevant screening for the Canadian population. We achieved this important milestone only thanks to the extraordinary commitment and dedication of our people from our research and development center in Gerenzano", commented Carlo Rosa, CEO of the DiaSorin Group. "It is to them that I say thank you today, because they have allowed us, once again, to be recognized as one of the most innovative diagnostic players in the world".

For additional information, please contact:

Corporate Vice President Communication & Investor Relations Investor Relator Tel: +39.0161.487988 Tel: +39.0161.487567 riccardo.fava@diasorin.it emanuela.salvini@diasorin.it

Riccardo Fava Emanuela Salvini

DiaSorin

Headquartered in Italy and listed in the FTSE MIB Index, DiaSorin is a global leader in the In Vitro Diagnostic (IVD) field. For over 50 years, the Company has been developing, producing and marketing reagent kits for IVD worldwide. The Group has a presence on the 5 continents with 26 companies, 4 foreign branches, 5 manufacturing facilities and 5 research and development centers throughout the world. Through constant investments in research and development, and using its own distinctive expertise in the field of immunodiagnostics to deliver a high level of innovation, DiaSorin offers today the broadest range of specialty tests available in the immunodiagnostics market and new tests in the molecular diagnostics markets, which identify DiaSorin Group as the "Diagnostic Specialist".