BD MAX MRSA Assay Receives FDA Clearance

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), today announced it received FDA clearance to market the BD MAX MRSA molecular test in the United States. The assay is performed on the fully-automated BD MAX System and is designed to rapidly and accurately identify patients colonized with methicillin-resistant Staphylococcus aureus (MRSA). Rapidly and accurately identifying patients enables infection control measures to be implemented faster to reduce transmission and help prevent infection in vulnerable patients.

"The BD MAX MRSA assay is an easy-to-use, cost-effective method to identify patients colonized with this deadly superbug, which may support better outcomes for the patient and a safer hospital environment," says Tom Polen, president of BD Diagnostics Diagnostic Systems. "FDA clearance of the BD MAX MRSA test gives our customers a new level of automation to optimize MRSA surveillance testing."

According to the Institute for Healthcare Improvement, the total cost burden to the U.S. healthcare system from MRSA infections is estimated at more than $2.5 billion annually. MRSA infections primarily occur in people who have been in hospitals or other healthcare settings. MRSA can spread among patients or healthcare workers via direct contact with colonized patients and/or hospital surfaces.  Early identification of patients colonized with MRSA helps reduce the risk of transmission and infection, and helps to improve patient outcomes.

"BD MAX is an automated, bench-top molecular system designed to perform a broad range of molecular testing, offering unmatched flexibility and versatility," says Thomas Davis, MD, PhD, professor of pathology and laboratory medicine at the Indiana University School of Medicine, and Pathologist with Wishard Health Services and Indiana University Health Laboratories. "As the BD MAX assay portfolio continues to grow, the walk-away automation, standardized workflow and ease-of-use of the BD MAX System will allow laboratories to increase both the menu and efficiency of molecular testing to better meet the demands of clinicians."

The BD MAX MRSA assay is the second test cleared this year by the FDA on the BD MAX System.