BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR™ System

Rhea-AI Summary

BD (NYSE: BDX) received FDA 510(k) clearance and CE-IVDR/CE marking for its Enteric Bacterial Panel (EBP) and Enteric Bacterial Panel plus (EBP plus) for the BD COR™ System on Nov 3, 2025.

The molecular panels use PCR on the BD COR system to detect a broad range of GI bacterial pathogens from a single stool swab and run on a high-throughput automated system with capacity for nearly 1,650 tests and up to 1,000 sample results in 24 hours, plus up to 7 hours walk-away time and room-temperature reagents.

Positive

• Regulatory clearances: FDA 510(k) and CE marking for EBP and EBP plus
• High throughput: BD COR capacity ~1,650 tests; up to 1,000 results in 24 hours
• EBP plus unique detection: only high-throughput bacterial-only molecular panel detecting ETEC LT/ST genes
• Operational efficiency: up to 7 hours walk-away, <15 minutes load time, room-temperature reagents

Negative

• None.

Insights

Regulatory and Commercial Analyst

BD gained FDA 510(k) clearance and CE-IVDR certification on Nov. 3, 2025, enabling high‑throughput enteric bacterial testing on the BD COR™ System.

By securing both FDA 510(k) clearance and CE marking, BD can market its Enteric Bacterial Panel and Enteric Bacterial Panel plus on the BD COR™ System, a platform that automates molecular workflows and supports high daily throughput. The panels cover a broad set of bacterial GI pathogens, including Salmonella spp., Campylobacter spp., Shigella spp./EIEC, STEC, ETEC (LT/ST), Plesiomonas, Vibrio spp., and Yersinia enterocolitica; the EBP plus is described as the only high‑throughput bacterial‑only molecular panel detecting ETEC toxin genes. This regulatory clearance and CE certification remove formal market access barriers in the U.S. and EU for these specific assays and the COR platform in enteric diagnostics.

Adoption hinges on lab procurement cycles, instrument placement, reimbursement for molecular enteric panels, and user validation timelines. Operational claims—capacity for nearly 1,650 tests and up to 1,000 sample results in 24 hours—support deployment in high‑volume labs but require end‑user verification. The announced benefits (walk‑away time, room‑temperature reagents, quick load time) reduce labor and may improve throughput where reimbursement and lab workflows align.

Watch for instrument placement contracts, first commercial shipments, and published performance/validation data over the next 6–18 months as concrete uptake indicators. Also monitor payer coding or reimbursement decisions and real‑world lab validation outcomes that would materially affect utilization and revenue recognition within that horizon.

FRANKLIN LAKES, N.J., Nov. 3, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX) a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Conformité Européenne (CE) marking in the European Union for its Enteric Bacterial Panel* (EBP) and Enteric Bacterial Panel plus* (EBP plus) for the BD COR™ System.

By leveraging advanced Polymerase Chain Reaction (PCR) technology with streamlined testing for a broad range of gastrointestinal (GI) bacterial pathogens from a single stool swab sample, the panels simplify workflows helping clinicians deliver timely, targeted care. 

GI infections cause billions of illnesses and more than 1.7 million deaths globally each year, disproportionately affecting young children, older adults, and immunocompromised peopleⁱ. In the United States, diarrhea accounts for an estimated 179 million outpatient visits, 500,000 hospitalizations, and more than 5,000 deaths annually, resulting in approximately one episode of acute diarrheal illness per person per yearⁱⁱ. These figures highlight the urgent need for rapid, accurate diagnostics to improve outcomes and support antimicrobial stewardship.

"Traditional GI tests can take days, and when patients are experiencing symptoms such as diarrhea or vomiting, delays can be potentially life-threatening," said Nikos Pavlidis, worldwide president of BD Diagnostic Solutions. "With EBP and EBP plus, clinicians choose the panel that best fits their clinical needs to quickly identify specific pathogens from a single swab, streamlining lab workflows and enabling targeted treatment to help protect vulnerable patients."

BD EBP for BD COR™ System offers a wide range of targets for enteric bacterial pathogens, including Salmonella spp., Campylobacter spp. (jejuni and coli), Shigella spp./Enteroinvasive Escherichia coli (EIEC), and Shiga toxin-producing Escherichia coli (STEC).

BD EBP plus for BD COR™ System is the only high-throughput, bacterial-only molecular panel that detects Enterotoxigenic Escherichia coli (ETEC), heat-labile enterotoxin (LT) and heat-stable enterotoxin (ST) genes, enabling improved patient management through rapid identification for targeted treatment of this major cause of diarrheal illness and helping reduce unnecessary antibiotic useⁱⁱⁱ. The panel also identifies Plesiomonas shigelloides, Vibrio spp. (V. vulnificus, V. parahaemolyticus, V. cholerae), and Yersinia enterocolitica.

The panels are run on the BD COR™ System, which automates molecular lab workflows with capacity for nearly 1,650 tests while delivering up to 1,000 sample results in 24 hours with barcode-driven traceability and remote system management. It offers up to seven hours of walk-away time, requires under 15 minutes to load, and uses room-temperature reagents that require no reconstitution, maximizing efficiency and minimizing manual interaction.

BD also offers the BD MAX™ Enteric Bacterial, Extended Enteric Bacterial, Enteric Viral and Enteric Parasite targeted syndromic panels for timely, accurate detection of the most common bacterial, viral and parasitic pathogens responsible for infectious diarrhea.

"With the BD MAX™ System, BD has long supported flexible, efficient, reliable enteric pathogen testing with more than 10 assays across respiratory, hospital acquired infection, sexually transmitted infection, and women's health testing for hospitals, clinics, and reference labs," said Pavlidis. "The addition of these two enteric panels to the BD COR™ system enables high-volume laboratories to advance their standard of care and optimize operational workflows."

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 more than 70,000 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. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinson

Contacts:
Media	Investors
Fallon McLoughlin Director, Public Relations 201.258.0361  Fallon.Mcloughlin@bd.com	Adam Reiffe  Vice President, Investor Relations 201.847.6927         Adam.Reiffe@bd.com

ⁱ https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-21270-6
ⁱⁱ https://www.aafp.org/pubs/afp/issues/2022/0700/acute-diarrhea.pdf
ⁱⁱⁱ https://pmc.ncbi.nlm.nih.gov/articles/PMC5925700/pdf/e00148-18.pdf

 

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SOURCE BD (Becton, Dickinson and Company)

FAQ

What did BD announce about enteric bacterial testing on Nov 3, 2025 for BDX?

BD announced FDA 510(k) clearance and CE marking for EBP and EBP plus panels for the BD COR system on Nov 3, 2025.

How many tests can the BD COR system handle for BDX enteric panels?

The BD COR system offers capacity for nearly 1,650 tests and can deliver up to 1,000 sample results in 24 hours.

Which pathogens do BD EBP and EBP plus for BDX detect?

Panels detect Salmonella, Campylobacter (jejuni/coli), Shigella/EIEC, STEC; EBP plus also detects ETEC LT/ST, Plesiomonas, Vibrio spp., and Yersinia enterocolitica.

What operational benefits do the BD COR enteric panels provide for laboratories using BDX tests?

Benefits include automated workflows, up to 7 hours walk-away, <15 minute load time, barcode traceability, remote system management, and room-temperature reagents.

Will the BD COR enteric panels affect antibiotic stewardship for BDX customers?

BD says rapid identification from a single swab enables targeted treatment and can help reduce unnecessary antibiotic use.

How do BD COR enteric panels relate to existing BD MAX tests for BDX?

BD continues to offer BD MAX enteric and extended panels; the BD COR panels add a high-throughput bacterial-only option for larger labs.