Bruker’s Maldi Biotyper Approved by China Regulators

Bruker Corporation has received clearance from the China Food and Drug Administration (CFDA) to market and sell its IVD Maldi Biotyper System as a medical device in China for the identification of microorganisms isolated from human specimens.

Bruker claims its Maldi Biotyper-based microbial identification has major advantages compared to classical automated biochemical testing, including faster time to result (TTR) and better information with deeper and broader species coverage. Starting from a culture, the IVD Maldi Biotyper allows for microbial identification in a few minutes without further time-consuming incubation steps.

“The regulatory approval of the IVD Maldi Biotyper System in China is a major milestone,” said Wolfgang Pusch, Ph.D., executive vice president of the Microbiology Business at Bruker Daltonics. “We are committed to supporting our customer base in China. After the regulatory approval, we have received positive feedback and have seen strong demand for the IVD Maldi Biotyper from the Chinese clinical microbiology market.”

With a paradigm shift in clinical practice, microbial identification typically is available one day earlier than with biochemical techniques. Additionally, Maldi-TOF mass spectrometry-based identification does not have the limitations of biochemical testing and can analyze species that have been difficult to identify by previous microbiology techniques, Bruker executives noted in a news release.

An increasing number of case reports describe the identification of microorganisms causing human infections which previously have been isolated only from environmental sources. The IVD Maldi Biotyper reference library now covers more than 2,300 microbial species of gram-negative bacteria, gram-positive bacteria, anaerobes and yeasts, and often enables the identifications of unexpected microorganisms.

The IVD Maldi Biotyper System includes the bench-top microflex Maldi-TOF (matrix-assisted laser desorption ionization time-of-flight) mass spectrometer, automated analysis software, the IVD Bacterial Test Standard (BTS), a 96-spot Maldi target and a library of microorganism reference entries. The microflex is the Maldi-TOF mass spectrometer for microbiology with a number of features specifically designed for applications in routine laboratories:

• State-of-the-art benchtop system to save lab space
• Fiber optics laser coupling for optimized robustness after preventive maintenance or service
• Self-cleaning ion source for optimized robustness in high-throughput applications
• Oil-free membrane pump for quiet operation in routine laboratories
• Rapid exchange of target plates to reduce delays between measurement runs
• Smart Spectra Acquisition saves laser life-time and increases speed of analysis

“The importance of Maldi-TOF mass spectrometry technology in the clinical microbiology field is widely recognized in mainland China now. The approval of Bruker´s IVD Maldi Biotyper system will promote the development of clinical microbiology science in the country, not only in laboratory medicine, but also for infection control work within the hospitals,” said Lisong Shen, M.D., director of Laboratory Medicine at Xin Hua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, and president of the Shanghai Society of Laboratory Medicine. “With the significant reduction of the time-to-result for identification of pathogenic bacteria, patient outcomes will improve and the cost of care will be reduced significantly.”

Since receiving the CE Mark in 2009, Bruker has expanded the species coverage of the the IVD Maldi Biotyper system and the geographic coverage of regulatory clearance. The IVD Maldi Biotyper now is available in most of Europe as well as Canada, Argentina, Colombia, Ecuador, Mexico, Japan, China, Hong Kong, Singapore, Taiwan and Australia. In November 2013 the Maldi Biotyper CA System received clearance for a first claim by the U.S. Food and Drug Administration.

The MALDI Biotyper family of systems enables molecular identification, and taxonomical classification or dereplication of microorganisms like bacteria, yeasts and fungi. Classification and identification of microorganisms is achieved using proteomic fingerprinting by high-throughput Maldi-TOF mass spectrometry. The Maldi Biotyper uses a molecular approach based on specific proteomic fingerprints from bacterial strains.

Applications of the various Maldi Biotyper solutions include clinical routine microbial identification, veterinary applications, use by national, regional or local health and other regulatory agencies, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety and quality control, as well as marine microbiology.

Bruker is a provider of scientific instruments and solutions for molecular and materials research, as well as for industrial, diagnostics and applied analysis.