BD MAX™ MRSA Assay Receives a CLIA Moderate Complexity Rating
Contact: Jamie Yacco
Baltimore, MD (August 14, 2012) – BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), today announced that the new BD MAX™ MRSA molecular test has received a Moderate Complexity rating under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88). Performed on the fully-automated BD MAX™ System, the assay is designed to rapidly and accurately identify patients colonized with methicillin-resistant Staphylococcus aureus (MRSA). A Moderate Complexity rating allows the BD MAX MRSA assay to be performed by a qualified laboratory technician.
“The BD MAX MRSA assay enables efficient use of labor in the laboratory,” said Tom Polen, President, BD Diagnostics – Diagnostic Systems. “Healthcare institutions can now simplify and optimize their MRSA active surveillance testing in less than a minute of hands-on time per specimen with true walk-away automation.”
According to a recent national survey conducted by the Association for Professionals in Infection Control and Epidemiology, more than three quarters of healthcare facilities in the United States now conduct active surveillance testing to detect patients colonized with MRSA. Active detection and isolation of MRSA-colonized patients have been shown to help prevent transmission and reduce the rate of MRSA infections in hospitals. Rapid detection with molecular methods helps decrease unneeded preemptive isolation and shortens the time that patients are not properly isolated.
Earlier this year, the BD MAX™ GBS assay for Group B Streptococcus received a Moderate Complexity rating. The BD MAX MRSA is the next assay to receive a Moderate Complexity rating. “This latest achievement further emphasizes our commitment to deliver a broad menu of molecular tests with a simplified, standardized workflow to help laboratories better meet the needs of healthcare providers,” said Polen.
About BD MAX™ System
BD MAX is the first and only fully automated, bench-top molecular system designed to perform a broad range of molecular tests. This includes in vitro diagnostic assays, as well as user-defined protocols and life science research applications. BD MAX GBS and BD MAX MRSA assays are commercially available in the United States today, and more than 15 state-of-the-art assays are currently under development.
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.