Waters Corporation announced that the BD BACTEC FXI Culture System has received CE marking under the European Union's In Vitro Diagnostic Regulation (IVDR), enabling commercialisation in Europe and representing a key milestone in the Company's clinical microbiology portfolio expansion. The BD BACTEC FXI System is a next-generation, fully automated blood culture system designed to improve the speed, consistency, and accuracy of bloodstream infection diagnostics in modern microbiology laboratories.
Clinical study data show that the BD BACTEC FXI System delivers a mean time to detection approximately three hours faster (~15 per cent reduction) than the previous generation BD BACTEC FX System, supporting earlier detection of pathogens and more timely initiation of targeted antimicrobial therapy in patients with suspected bloodstream infections and sepsis. In 2021, sepsis-related deaths represented 31.5 per cent of total global deaths, with studies showing that each hour of delay in antibiotic administration is associated with increased odds of mortality.
"In the context of sepsis, diagnostics are critical to supporting informed clinical decision-making and ultimately improving antimicrobial stewardship and patient care," said Rafael Cantón, PhD, Head of Clinical Microbiology, University Hospital Ramón y Cajal – IRYCIS, Madrid. "Based on our experience during clinical trials, the BD BACTEC FXI System reflects a mature and robust approach to blood culture diagnostics, with a clear focus on system reliability, ease of use, and laboratory workflow."
A key innovation of the BD BACTEC FXI System is its automated gravimetric measurement of individual blood culture vial volume, the first-of-its-kind capability in a blood culture platform. Studies indicate up to 85 per cent of blood culture vials are inappropriately filled in routine clinical practice, negatively impacting diagnostic accuracy. By objectively confirming blood volume in each vial, the system addresses a well-established source of pre-analytical variability and supports improved diagnostic consistency and adherence to recommended collection practices.
The BD BACTEC FXI System is designed for modern, high-throughput microbiology laboratories, featuring fully automated workflows including vial loading, unloading, incubation, and detection alerts. It offers an industry-leading automated loading capacity of up to 60 vials at a time, reducing manual intervention and significantly increasing walkaway time. In addition, the BD BACTEC FXI System offers flexibility and right-sized solutions for labs of varying sizes, with modules accommodating 480 and 960 vials, enabling laboratories to efficiently manage high testing volumes while allowing staff to focus on more clinically important tasks.
"The BD BACTEC FXI Culture System represents a significant advancement in automated microbiology, combining speed, automation, and scalability to support laboratory modernisation," said Jianqing Bennett, Senior Vice President, Waters Advanced Diagnostics, Waters Corporation. "This system strengthens our position in clinical microbiology and expands our ability to address the growing global demand for faster, more reliable infectious disease testing."
