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BD Expands BD MAX™ System Menu with New IVDR-Certified VIASURE Assays in Partnership with Certest Biotec
Prnewswire· 2025-12-15 21:40
Core Insights - BD (Becton, Dickinson and Company) has expanded its respiratory and STI diagnostics offerings in Europe with the IVDR certification of two new VIASURE assays for the BD MAX™ System, enhancing the detection capabilities for a wide range of pathogens [1][2] Group 1: Product Expansion - The newly certified assays include a respiratory virus detection kit that identifies multiple viruses such as SARS-CoV-2, flu (A and B), RSV, and others from a single nasopharyngeal swab, and an assay for herpes simplex viruses and Treponema pallidum from skin lesion swabs [5][6] - The BD MAX™ System can process up to 24 samples per run and provides results in approximately three hours with less than one minute of hands-on time per sample, supporting timely and reliable clinical decision-making [2][4] Group 2: Strategic Partnership - The partnership with Certest Biotec, which began in 2017, has been crucial for BD in expanding its diagnostic menu and is expected to lead to further innovative projects in the future [3][6] - Certest Biotec specializes in the development and commercialization of in vitro diagnostic medical devices, contributing to BD's broad portfolio in human diagnostics [5][6] Group 3: Company Overview - BD is one of the largest global medical technology companies, focusing on improving medical discovery, diagnostics, and care delivery, with a commitment to enhancing safety and efficiency in healthcare [4] - The company employs over 70,000 individuals and collaborates with organizations worldwide to address significant global health challenges [4]
BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR™ System
Prnewswire· 2025-11-03 11:50
Core Insights - BD (Becton, Dickinson and Company) has received FDA 510(k) clearance and CE marking for its Enteric Bacterial Panel (EBP) and Enteric Bacterial Panel plus (EBP plus) for the BD COR™ System, enhancing diagnostic capabilities for gastrointestinal infections [1][2]. Group 1: Product Features and Benefits - The EBP and EBP plus utilize advanced Polymerase Chain Reaction (PCR) technology to test a wide range of gastrointestinal bacterial pathogens from a single stool swab, streamlining workflows for clinicians [1][2]. - The EBP plus is the only high-throughput, bacterial-only molecular panel that detects Enterotoxigenic Escherichia coli (ETEC) and associated toxins, improving patient management and reducing unnecessary antibiotic use [3]. - The BD COR™ System can automate nearly 1,650 tests and deliver up to 1,000 sample results in 24 hours, maximizing efficiency with minimal manual interaction [4]. Group 2: Market Context and Impact - Gastrointestinal infections lead to over 1.7 million deaths globally each year, with significant healthcare burdens in the U.S., including 179 million outpatient visits and 500,000 hospitalizations annually due to diarrhea [1]. - The introduction of these panels addresses the urgent need for rapid and accurate diagnostics, which is critical for improving patient outcomes and supporting antimicrobial stewardship [1][2]. Group 3: Company Overview - BD is one of the largest global medical technology companies, focused on advancing health through innovative technology and solutions that enhance clinical therapy and healthcare delivery [7][8]. - The company has a strong commitment to improving the safety and efficiency of healthcare processes, with a presence in virtually every country and partnerships aimed at addressing global health challenges [8].