BD Receives FDA 510(k) Clearance and CE‑IVDR Certification for New High‑Throughput Enteric Bacterial Panels

BDX
November 03, 2025

BD secured FDA 510(k) clearance and CE‑IVDR certification for its Enteric Bacterial Panel (EBP) and Enteric Bacterial Panel plus (EBP plus) on the BD COR system, expanding its high‑throughput gastrointestinal testing portfolio.

The panels use polymerase chain reaction technology to detect Salmonella, Campylobacter, Shigella, STEC, ETEC, Vibrio, and Yersinia from a single stool swab, enabling rapid, targeted treatment decisions and supporting antimicrobial stewardship.

The BD COR system can run up to 1,650 tests and deliver up to 1,000 results in 24 hours, with a seven‑hour walk‑away time and minimal manual handling, positioning BD to meet growing demand for rapid, accurate pathogen detection in clinical laboratories.

BD’s diagnostics segment has grown 7.86% year‑over‑year, and the new panels are expected to contribute to continued revenue growth as the company expands its high‑throughput capabilities and integrates the panels with its existing BD MAX platform.

The launch aligns with BD’s broader strategy to separate its Biosciences and Diagnostic Solutions businesses, and it strengthens BD’s competitive position in the high‑throughput GI testing market, where it competes with companies such as Roche, Thermo Fisher, and Luminex.

Management highlighted that the EBP plus is the only high‑throughput, bacterial‑only molecular panel that detects ETEC heat‑labile and heat‑stable toxin genes, underscoring its unique selling proposition.

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