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BD Gets FDA Clearance for Enteric Bacterial MDx Test

NEW YORK (GenomeWeb) – Becton Dickinson said today that the US Food and Drug Administration has given it 510(k) clearance for a molecular test that detects infectious diarrhea caused by harmful intestinal bacteria.

The test is an extension to the firm's BD MAX real-time PCR enteric bacterial panel. With the clearance, the majority of pathogens causing acute gastroenteritis leading to hospitalization can be detected rapidly and accurately on the fully automated BD MAX molecular platform, BD said.

It is BD's latest offering in the suite of BD MAX enteric assays that aid in detecting and diagnosing acute gastroenteritis, an inflammation of the gastrointestinal tract.

This panel joins the BD MAX enteric bacterial panel and the BD MAX enteric parasite panel, enabling individualized testing to be performed based on a patient's symptoms and health history, the firm said.

Doug White, vice president and general manager of molecular diagnostics and women's health for BD, said in a statement that the BD MAX system "allows the diagnostic laboratory to perform molecular testing in a flexible, automated manner, enabling timely results and more efficient patient manage­ment."

According to the Centers for Disease Control and Prevention, 1 in 6 Americans suffers from infection due to food-borne illness each year.