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FDA Clears BD Max Enteric Bacterial Panel

NEW YORK (GenomeWeb) – Becton Dickinson today said that the US Food and Drug Administration has cleared for marketing the firm's BD Max Enteric Bacterial Panel for detecting the common causes of bacterial gastroenteritis.

The panel is a qualitative test that detects DNA from Campylobacter spp. (jejuni and coli), Salmonella spp., Shigella spp. / Enteroinvasive E. coli (EIEC) as well as stx 1 and stx 2 genes in stool specimens. According to BD, these pathogens are responsible for up to 95 percent of bacteria-causing gastroenteritis and account for millions of deaths annually.

The panel runs on the BD Max System, which automates sample preparation, extraction, amplification, and detection on a single system.

"The BD Max Enteric Bacterial Panel will provide clinicians with fast, accurate results that will enable more rapid diagnosis compared with conventional culture methods and will help improve standard of care and clinical efficiencies," Doug White, VP and GM of Molecular Diagnostics & Women's Health, BD Diagnostics, said in a statement.

He noted that the panel is the first FDA-cleared assay in the BD MAX Enteric portfolio, and the firm plans to add additional panels that include viral, parasite, and extended bacterial detection.

The firm's BD MAX Enteric Parasite Panel, which detects the parasitic enteric pathogens Giardia lamblia, Cryptosporidium, and Entamoeba histolytica directly from stool specimens, recently was CE marked for sale in Europe. The Enteric Bacterial panel was E marked in March 2013, said BD.