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BD Obtains CE Mark for Molecular TB, MDR-TB Assay

NEW YORK (GenomeWeb) – Becton Dickinson said today that its BD Max MDR-TB panel has received CE-IVD status and is now available in Europe.

The PCR-based panel is intended to help detect tuberculosis-causing bacteria and determine if the bacteria contains mutations associated with resistance to isoniazid and rifampicin, two important first-line TB drugs.

The assay runs on the BD Max system, a fully integrated and automated molecular diagnostics platform that can run up to 24 samples across multiple tests and provides results for most assays in less than three hours.

BD said that the MDR-TB panel complements its BD Bactec MGIT system for comprehensive drug susceptibility and resistance testing.

The company said that preliminary results from an international clinical study of the new assay will be presented next week at the 49th Union World Conference on Lung Health (TB Union) at The Hague in The Netherlands.