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GEN News Highlights : Jul 10, 2012

FDA Clears BD MAX MRSA Test

Becton Dickinson’s Diagnostics operation received FDA clearance to market the BD MAX™ MRSA molecular test. The assay is carried out on the automated BD MAX system, and is designed to rapidly identify patients infected with methicillin-resistant Staphylococcus aureus (MRSA).

“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," remarks Tom Polen, President, 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."

The BD MAX MRSA assay is the second test cleared by FDA for the BD MAX system this year. In March the agency approved the BD MAX Group B Streptococcus (GBS) Assay and Clinical Laboratory Improvement Amendments (CLIA) moderate complexity test categorization on the second-generation BD MAX system. The BD MAX GBS assay is an in vitro diagnostic test for detection of GBS DNA in Lim Broth cultures.