#United States #Franklin Lakes #Becton Dickinson #Enteric Bacterial Panels #BD COR System

BD Achieves FDA 510(k) Clearance and CE-IVDR Certification for Enteric Bacterial Panels

Becton, Dickinson and Company (BD), a prominent player in the medical technology field, has recently announced significant advancements in gastrointestinal diagnostics with the receipt of the FDA 510(k) clearance and CE-IVDR certification in the European Union. These approvals pertain to their innovative Enteric Bacterial Panel (EBP) and Enteric Bacterial Panel plus (EBP plus), which are intended for use with the BD COR™ System.

Gastrointestinal (GI) infections are responsible for billions of illnesses and numerous fatalities each year—over 1.7 million deaths globally—especially impacting young children, the elderly, and individuals with weakened immune systems. In the United States alone, diarrhea leads to approximately 179 million outpatient visits annually, which underscores the pressing necessity for rapid, accurate diagnostic solutions in healthcare.

The Problem with Traditional GI Testing

Traditional methods of detecting GI pathogens can impose delays of several days, potentially resulting in life-threatening complications for patients displaying acute symptoms like diarrhea or vomiting. Nikos Pavlidis, the worldwide president of BD Diagnostic Solutions, emphasized that quick identification of specific pathogens from a single stool sample can dramatically improve treatment pathways and patient outcomes.

Key Features of the BD Panels

The Enteric Bacterial Panel for the BD COR™ System stands out by detecting a wide array of enteric pathogens, including:

• - Salmonella spp.
• - Campylobacter spp. (jejuni and coli)
• - Shigella spp./Enteroinvasive Escherichia coli (EIEC)
• - Shiga toxin-producing Escherichia coli (STEC)

In addition, the EBP plus panel uniquely identifies Enterotoxigenic Escherichia coli (ETEC) and its associated toxin genes, thus facilitating better management of diarrheal illnesses while supporting antimicrobial stewardship efforts by reducing unnecessary antibiotic prescriptions. The panel also screens for pathogens like Plesiomonas shigelloides and various Vibrio species.

Enhancements in Laboratory Efficiency

Utilizing advanced Polymerase Chain Reaction (PCR) technology, the BD COR™ System can process nearly 1,650 tests, delivering results for up to 1,000 samples within a 24-hour window. This level of automation allows for an impressive walk-away time of up to seven hours, requiring less than 15 minutes for initial setup, and uses room-temperature reagents for additional efficiency.

BD also offers the BD MAX™ system, which includes other targeted panels for enteric pathogens, demonstrating the company's commitment to improving diagnostic capabilities across various healthcare settings. The inclusion of the new enteric panels provides high-volume labs an opportunity to uplift their standards of care and optimize their operational workflows.

A Commitment to Health Innovation

As one of the largest global medical technology firms, BD is dedicated to advancing healthcare by enhancing medical discovery and diagnostic processes. With over 70,000 employees worldwide, BD aims to not only improve safety and efficiency for healthcare professionals but also to enable accurate disease detection and promote innovative therapeutic developments.

In collaborating closely with healthcare providers, BD continuously strives to address critical global health challenges, improve health outcomes, and expand access to healthcare.

For more details or to connect with BD, visit their official website at bd.com. Follow them on LinkedIn or Twitter for the latest updates on their products and initiatives to enhance patient care.