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New Assay Rapidly Identifies Lethal Pathogen Responsible for Clostridium difficile Infection


BD MAX™Cdiff Test Launches in Europe, Expanding HAI Portfolio on BD MAX™ System

 

 

Contact:

Vikki Lomas

Corporate Communications

(+44) 1865 781607

Email: Vikki_Lomas@europe.bd.com

 

Baltimore, MD (April 2012) – BD Diagnostics, a segment of BD (Becton, Dickinson and Company), today announced that it obtained CE Marking of the BD MAX™ Cdiff Assay. The assay detects the toxin B gene (tcdB), which has been shown to be present in all toxigenic C. difficile and is essential for disease.

Run on the fully automated BD MAX™ System, the assay is designed to rapidly and accurately identify patients with Clostridium difficile infection (CDI), including those caused by hypervirulent strains. Rapidly and accurately identifying these patients enables appropriate treatment and infection control measures to be implemented quickly, which may improve patient outcomes.

“As CDI rates continue to increase in healthcare facilities worldwide, rapid molecular testing for detection of toxigenicC. difficile can help expedite appropriate treatment, reduce length of stay, and improve patient outcomes,” said Tom Polen, President, BD Diagnostics – Diagnostic Systems.  “The BD MAX Cdiff Assay launch is another important milestone in our effort to deliver a range of clinical tests on the BD MAX System, offering laboratories improved efficiency, turnaround time, and productivity.”

According to a recent study in theAmerican Journal of Infection Control, nucleic acid amplification tests provide better sensitivity over enzyme immunoassay and glutamate dehydrogenase testing algorithms for detection of toxigenic C. difficileC. difficile is a gram-positive bacterium that is responsible for the development of antibiotic-associated diarrhea and colitis that can progress to toxic megacolon, sepsis and death.  More than 95 percent of antibiotic-associated pseudomembranous colitis cases are caused by CDIs, resulting in more than $1 billion in healthcare costs annually.

The BD MAX Cdiff Assay represents the third CE-Marked assay on the BD MAX, the first fully automated bench-top molecular system designed to perform a broad range of molecular testing. The BD MAX System was developed to offer laboratories a simplified platform with true walk-away automation and the versatility to perform a broad range of molecular tests.

For more information on the BD MAX System, please visit:

http://www.bd.com/geneohm/english/products/max/instrument/

 

About BD

BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 29,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.