BD Receives FDA 510(K) Clearance for Molecular Test for Harmful Intestinal Bacteria Causing Infectious Diarrhea

Extends BD MAX™ Enteric Panel Portfolio with latest Molecular Test that Targets Infectious Diarrhea

Jun 5, 2017

FRANKLIN LAKES, N.J., June 5, 2017 – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that its newly developed molecular test for detecting harmful intestinal bacteria causing infectious diarrhea has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

According to the Centers for Disease Control and Prevention (CDC), one in six Americans suffers from infection due to food-borne illness each year.1 With the availability of the BD MAX extended enteric bacterial panel, the majority of pathogens causing acute gastroenteritis2 leading to hospitalization can be detected rapidly and accurately on the fully automated BD MAX molecular platform.

The BD MAX extended enteric bacterial panel is the latest offering in the suite of BD MAX enteric assays, which aid in the detection and diagnosis of 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.

“Thanks to the continued innovation and extended ability of the BD MAX enteric suite to adapt testing to the patient population, geography and clinical presentation, clinical laboratories are able to focus on what’s truly important ─ their patients,” said Dr. Joel Mortensen, managing director for Mortensen and Associates, LLC, a microbiology and molecular diagnostics consulting firm.

Doug White, vice president and general manager of Molecular Diagnostics and Women’s Health for BD said, “We continue to expand the BD MAX system menu of unique, clinically relevant panels. 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.”

The BD MAX menu includes syndromic panels for health care associated infections, reproductive and sexually transmitted infections and enteric pathogens, aiding lab professionals in their efforts to deliver diagnostic results that positively impact patient care while improving lab operations and decreasing time to results as compared to conventional methods.

The BD MAX system automates real-time PCR testing by performing the necessary steps of sample extraction, amplification and detection on a single system. It also features open system capability, allowing for the automated performance of “in house” molecular assays.

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

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Troy Kirkpatrick

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Monique N. Dolecki

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  1. CDC Food Safety website, September 2016. safety/foodborne-germs.html
  2. Incidence and trends of infection with pathogens transmitted commonly through food – Foodborne Disease Active Surveillance Network, 10 US sites 1996-2012. MMWR April 2013; 62:15; 283-287.