February 21, 2017 - Saluggia (VC) - DiaSorin (FTSE Italia Mid Cap: DIA) announced today that they have received clearance from the US Food and Drug Administration to market the Simplexa C. difficile Direct Assay for the detection of Clostridium difficile (C. difficile).
The assay, already launched outside of the US in November 2016, was developed by DiaSorin Molecular to be run on the LIAISON® MDX. It is a scalable small bench-top instrument able to provide reliable, clinically validated, real-time PCR results for quantitative, qualitative, multi-analyte and sample-to-answer detection needs.
Clostridium difficile Infection (CDI) is a major cause of antibiotic-associated diarrhea and colitis and is transmitted from person to person, by the fecal-oral route or acquired from environmental sources that have been contaminated.
“C. difficile bacterial infections occur in all age groups and may be life-threatening, especially in elderly and immunocompromised patients,” said Michelle Tabb, Vice President of Research and Development, DiaSorin Molecular LLC. “Earlier intervention may lead to more effective infection control measures in a time where CDI is increasing the burden on healthcare systems with extended patient bed days, high readmission and mortality rates for susceptible patients.”
According to the Centers for Disease Control and Prevention (CDC), approximately 15,000 deaths were attributed to CDI each year in the US and studies indicate that C. difficile has become the most common microbial cause of healthcare-associated infections in US hospitals costing up to $4.8 billion in excess health care costs.
“The launch of C. Difficile molecular assay in US allow us to strengthen our positioning as a reliable infectious diseases company in a market where we see interesting growth opportunities,” commented Carlo Rosa, Chief Executive Officer of DiaSorin Group. “Our new assay is able to address the needs of hospital laboratories in regards to workflow and lab efficiency and have a positive impact on identifying C. difficile, leading to improve patient management.”
Headquartered in Italy and listed in the FTSE Italia Mid Cap Index, DiaSorin is a global leader in the In Vitro Diagnostics (IVD) field. For over 40 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 diagnostic field to deliver a high level of innovation, DiaSorin offers today the broadest range of specialty tests available in the immunodiagnostic market and a broad number of molecular diagnostic tests, which identify DiaSorin Group as the IVD “diagnostics 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