BD MAX™ Cdiff Assay Receives FDA Clearance
BALTIMORE, April 9, 2013 /PRNewswire/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it received FDA clearance to market the BD MAX™ Cdiff Assay in the United States. The assay is performed on the fully-automated BD MAX™ System and is designed to rapidly and accurately detect the toxin B gene (tcdB), which has been shown to be essential to cause disease, in patients suspected of Clostridium difficile infection (CDI).
Rapid, accurate identification of patients with CDI enables timely and appropriate therapy and infection control interventions to prevent the spread of this infection in healthcare institutions. Use of molecular testing has been proven to reduce the number of healthcare facility-associated cases of CDI.i The assay was CE-marked in March 2012 and has demonstrated excellent performance in Europe.ii
"The BD MAX Cdiff assay is a simple, easy-to-use, fully-automated method for detection of these dangerous bacteria," said Tom Polen, President, BD Diagnostics – Diagnostic Systems. "FDA clearance of the BD MAX Cdiff assay gives our customers the ability to balance productivity and cost as they perform laboratory testing for an expanding menu of infectious diseases."
According to the U.S. Centers for Disease Control and Prevention, CDIs are a growing threat in hospitals, nursing homes and other healthcare settings. Infection rates are at historically high levels, killing 14,000 Americans each year and adding more than $1 billion in excess costs to the healthcare system. The National Action Plan to Prevent Healthcare-Associated Infections is targeting a 30 percent reduction of CDI rates, which may be prevented through a combination of infection control interventions and appropriate use of antibiotics.iii
The BD MAX™ Cdiff assay is the third FDA-cleared assay on the BD MAX™ System. Other available assays include BD MAX™ MRSA for the detection of methicillin-resistant Staphylococcus aureus and BD MAX™ GBS for the detection of Group B Streptococcus. Both assays were categorized by FDA as CLIA Moderate Complexity tests. This latest milestone represents further confirmation of BD's commitment to rapidly expand its menu, offering laboratories a broad range of molecular tests that meet both their current and future clinical needs.
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 nearly 30,000 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.
i. Catanzaro et al., 2012 Real-time polymerase chain reaction testing for Clostridium difficile reduces isolation time and improves patient management in a small community hospital. AJIC 40:663-666
ii. Le Guern et al., 2012 Evaluation of a New Molecular Test, the BD Max Cdiff, for Detection of Toxigenic Clostridium difficile in Fecal Samples. J. Clin. Microbiol. 2012, 50:3089-3090
iii. MMWR. March 9, 2012. Vital Signs: Preventing Clostridium difficile Infections