FDA has granted premarket notification (510(k)) clearance to BD, Franklin Lakes, NJ, for its newly developed molecular test for detecting harmful intestinal bacteria causing infectious diarrhea.
With the availability of the BD Max extended enteric bacterial panel, the majority of pathogens causing acute gastroenteritis leading to hospitalization can be detected rapidly on the fully automated BD Max molecular platform.
The 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. The 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.
“We continue to expand the BD Max system menu of unique, clinically relevant panels,” says Doug White, vice president and general manager of molecular diagnostics and women’s health at BD. “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 healthcare-associated infections, reproductive and sexually transmitted infections, and enteric pathogens, aiding lab professionals in their efforts to deliver diagnostic results that positively affect patient care while improving lab operations and decreasing time to results as compared to conventional methods.
The system automates real-time polymerase chain reaction 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.
For more information, visit BD.