Press Release

DIASORIN LAUNCHES SIMPLEXA BORDETELLA DIRECT MOLECULAR TEST IN THE UNITED STATES

January 3, 2019 - Saluggia (VC) - DiaSorin (FTSE MIB: DIA) received FDA clearance for its new Bordetella molecular diagnostic test. Simplexa Bordetella Direct is designed to quickly provide qualitative detection and differentiation of both Bordetella pertussis and Bordetella parapertussis in human nasopharyngeal swabs. The assay was launched in the European market in December 2017.

Pertussis, or whooping cough, is a highly contagious disease of the respiratory system caused by small, gram-negative B. pertussis and B.parapertussis bacteria. While most of the cases are caused by B. pertussis, some milder cases have been linked to B. parapertussis. Pertussis can lead to hypoxia, permanent brain damage or death, particularly in infants.

Since the late 1990s, there has been a marked increase in the number of reported pertussis cases in developed countries in spite of high vaccination rates. There were more than 48,000 cases reported in the United States in 2012, the highest number of reported cases since 1955. The World Health Organization estimates that there are 50 million whooping cough cases worldwide each year, resulting in 350,000 deaths.

"Whooping cough can be detected among all age groups and has seen a resurgence in recent years," said Michelle Tabb, Vice President of Research and Development, DiaSorin Molecular LLC. "We are very excited about our addition of the Simplexa Bordetella Direct assay as it will help in the detection and appropriate treatment of this infectious disease also in United States. The assay, designed for the use on the LIAISON MDX platform, meets the needs of today's laboratories by detecting both B. pertussis and B. parapertussis with a simple workflow."

About 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. 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".

For additional information, please contact:

Riccardo Fava

Ines Di Terlizzi

Investor Relations & Corporate Communication Senior Director

Investor Relator

Tel: +39.0161.487988

Tel: +39.0161.487567

riccardo.fava@diasorin.it

ines.diterlizzi@diasorin.it

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DiaSorin S.p.A. published this content on 03 January 2019 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 03 January 2019 12:28:04 UTC