Industry News: FDA Clearance Received for C. Difficile Assay on Liaison MDX qPCR Platform

13 Sep 2017


DiaSorin Molecular has 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.

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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.”