DiaSorin Molecular, Cypress, Calif, has announced the United States introduction of its Simplexa C. difficile direct assay, upon receiving premarket notification (510(k)) clearance from FDA. The new assay runs on the company’s Liaison MDX qPCR system, a scalable benchtop instrument that delivers qualitative and quantitative, sample-to-answer, multianalyte results. The Simplexa assay detects the Clostridium difficile toxin B gene, 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 United States alone.
Michelle Tabb, PhD, DiaSorin Molecular.
“C. difficile bacterial infections strike all age groups and are particularly serious in older and immunocompromised patients,” says Michelle Tabb, PhD, vice president for research and development at DiaSorin Molecular. “Our new assay, which has demonstrated low invalid rates, will help in earlier detection and intervention.”
For more information, visit DiaSorin Molecular.
