BD Diagnostics, a segment of BD (Becton, Dickinson and Company), and Bruker Daltonics Inc., a subsidiary of Bruker Corporation, announced an international co-development and co-marketing collaboration that will promote an emerging, integrated approach to bacterial and fungal identification and antimicrobial susceptibility testing. This new approach has the potential to transform how traditional microbiology has been performed for decades. Through this collaboration, identification of microorganisms will be performed with the Bruker MALDI Biotyper, a mass spectrometry-based proteomic "fingerprinting" system specifically configured for rapid identification of bacteria, yeast and fungi. The MALDI Biotyper is available in a clinical version with IVD-CE mark in Europe and is for research use only (RUO) in the United States, where Bruker intends to seek FDA clearance.
BD and Bruker intend to combine the MALDI Biotyper microbial ID system with automated antimicrobial susceptibility testing on the BD Phoenix(TM) Microbiology System. The BD EpiCenter(TM) Microbiology Data Management System, which will manage patient data from both the identification and the susceptibility test systems, will facilitate this industry-first integrated approach. The MALDI Biotyper -- BD EpiCenter software integration will be further developed to optimize workflows for rapid MALDI Biotyper pathogen identification directly on positive blood cultures from the leading BD BACTEC(TM) blood culture system. This rapid blood culture-to-ID workflow is supported by Bruker's new MALDI Sepsityper® consumables kit, which today is for RUO. It is expected to become clinically important in the future, as time-to-result for pathogen identification is critical to management of patients having potentially serious bloodstream infections or sepsis. Microbial identification and antimicrobial susceptibility testing is the end-point of the major work a microbiology lab performs on a daily basis. After culturing and isolating bacteria and fungi from patient specimens, organisms need to be identified and tested to determine which drugs will inhibit or stop their growth.
The Bruker MALDI Biotyper allows highly accurate, rapid and cost-effective identification through a process in which organisms are identified by the unique spectrum of the major proteins and peptides that constitute their makeup. The accuracy and benefits of the MALDI Biotyper have been well documented in over 30 peer-reviewed articles. Antimicrobial susceptibility testing is conducted via traditional automated systems such as the BD Phoenix System. The combination of the two leading technologies, the BD Phoenix System and the MALDI Biotyper, and the data management through the BD EpiCenter System, will provide laboratorians with a groundbreaking new approach to identification and susceptibility testing, which will reduce the turnaround time for critical diagnostic results, while also improving laboratory efficiency and costs.