Becton Dickinson (NYSE:BDX) said today that it won 510(k) clearance from the FDA for its molecular test that detects harmful intestinal bacteria causing infectious diarrhea.
With the approval of its BD Max extended enteric bacteria panel, the company said the majority of pathogens causing acute gastroenteritis can be detected on its automated BD Max molecular platform.
“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,” Joel Mortensen, managing director for Mortensen & Associates, said in prepared remarks.
“We continue to expand the BD Max system menu of unique, clinically relevant panels,” VP and GM of BD’s molecular diagnostics and women’s health businesses, Dough White, added. “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 portfolio includes panels for healthcare associated infections, reproductive and sexually transmitted infections and enteric pathogens. The system automates real-time PCR testing by performing sample extraction, amplification and detection on a single platform.