Great Basin Whooping Cough MDx Clears FDA

Apr 03, 2017

NEW YORK (GenomeWeb) – Great Basin Scientific has received 510(k) clearance for a molecular diagnostic test to detect Bordetella pertussis, the bacteria that causes whooping cough.

The sample-to-result test, called Bordetella Direct, runs directly from a patient nasopharyngeal swab using a fully-enclosed assay cartridge on the firm's diagnostic system, requiring less than one minute of hands-on time.

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