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BD Gets FDA OK for Group B Strep MDx Assay

NEW YORK (GenomeWeb News) – Becton Dickinson today said that the US Food and Drug Administration has cleared for marketing its BD Max Group B Streptococcus Assay for detection of GBS DNA in Lim Broth cultures.

BD said that the test, which runs on its second-generation BD Max System, received CLIA moderate complexity test categorization. It said that the test is the only automated IVD method for PCR detection of GBS from Lim Broth with a moderate complexity categorization.

Gregory Meehan, VP of BD Diagnostics – Diagnostic Systems, Molecular Diagnostics, said in a statement that the FDA clearance "moves BD closer to our goal of providing a next-generation molecular testing system designed to offer and accommodate a broad range of assays."

The firm is developing methicillin-resistant Staphylococcus aureus and Clostridium difficile assays to run on the system.

The Scan

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