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C. difficile assay cleared by FDA

19th September 2017

Posted By Paul Boughton


DiaSorin Molecular Receives FDA Clearance for Reliable C. difficile Assay on LIAISON MDX Platform.

DiaSorin Molecular today announced the US.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 bench-top 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 US 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 US hospitals. It is estimated that this infection costs $4.8 billion each year in the U. 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.”





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