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FDA Clears BD Diagnostics' MRSA Assay

NEW YORK (GenomeWeb News) – BD Diagnostics, a segment of Becton Dickinson, today announced that the US Food and Drug Administration has cleared the BD Max MRSA molecular test for marketing in the US.

The assay runs on the fully automated BD Max System and was developed to rapidly identify patients with methicillin-resistant Staphylococcus aureus.

"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," Thomas Davis, professor of pathology and laboratory medicine at the Indiana University School of Medicine, said in a statement.

The BD Max MRSA assay is the second test cleared this year by FDA on the BD Max System, following clearance in March of the BD Max Group B Streptococcus Assay for detecting GBS DNA in Lim Broth cultures.

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