DiaSorin Molecular Receives FDA Clearance for Reliable C. difficile Assay on LIAISON® MDX Platform Cypress, Calif. (September 12, 2017) – DiaSorin Molecular today announced the U.S. introduction of the Simplexa® C. difficile Direct Assay, upon receiving clearance from the Food and Drug Administration. The new assay runs on the company’s LIAISON® MDX qPCR system, a scalable benchtop instrument that delivers qualitative and quantitative, sample-to-answer, multi-analyte results. The Simplexa assay detects the Clostridium difficile toxin B gene (tcdB), present in liquid or unformed stool samples, aiding in the diagnosis of C. difficile infection. 

According to the Centers for Disease Control and Prevention, approximately 15,000 U.S. deaths are attributed to C. difficile infection each year, and studies indicate that C. difficile is now the most common microbial cause of infections in U.S. hospitals. It is estimated that this infection costs $4.8 billion each year in the U.S. alone. 

C. difficile bacterial infections strike all age groups and are particularly serious in older and immunocompromised patients,” said Michelle Tabb, vice president of research and development for DiaSorin Molecular. “Our new assay, which has demonstrated low invalid rates, will help in earlier detection and intervention.”  

About DiaSorin Molecular 

DiaSorin Molecular, LLC manufactures and distributes innovative molecular diagnostic products for hospital and reference laboratories. The company’s products help laboratories consolidate their testing, streamline processes, and increase efficiency. DiaSorin Molecular’s Simplexa® molecular diagnostic kits run on the company’s versatile LIAISON® MDX platform. The company provides service and support solutions for its kits and instruments through a global network of offices and distributors. DiaSorin Molecular also markets a range of ASRs (analyte-specific reagents) for use in lab-developed tests.