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The Bruker MALDI Biotyper(TM) Receives Clearance as a Medical Device from the China Food and Drug Administration (CFDA)

BRKR, BIOGY | June 25, 2014

Bruker Corporation (NASDAQ: BRKR) today announced that it 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.

Dr. Lisong Shen, the 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 (Photo: Business Wire)

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.

With this paradigm shift in clinical practice, microbial identification is typically 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.

An increasing number of case reports describe the identification of microorganisms causing human infections which previously have been isolated only from environmental sources. The comprehensive 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 an extensive library of microorganism reference entries. The microflex is the market-leading MALDI-TOF mass spectrometer for microbiology with a number of unique 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

Commenting on the CFDA clearance, Dr. Lisong Shen, the 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, said: “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 further promote the development of clinical microbiology science in the country, not only in laboratory medicine, but also for infection control work within the hospitals. With the significant reduction of the time-to-result for identification of pathogenic bacteria, the patient outcomes will improve and the cost of care will be reduced significantly.”

Dr. Lu Xinxin, the Director of the Clinical Laboratory Department at the Capital Medical University-Affiliated Beijing Tongren Hospital, added: “MALDI-TOF MS is a revolutionary technology in microbiology. It is rapid, easy to operate and enjoyable to navigate in the microbial world."

Dr. Wolfgang Pusch, Executive Vice President of the Microbiology Business at Bruker Daltonics, commented: “The regulatory approval of the IVD MALDI Biotyper System in China is a major milestone and another achievement in our regulatory strategy to support the future growth of our business. We are committed to fully supporting our growing customer base in China. After the regulatory approval, we have immediately received positive feedback and have seen strong demand for the IVD MALDI Biotyper from the Chinese clinical microbiology market.”

Fast species ID is an important component to improve antibiotic stewardship by helping to guide selection of the right therapeutic drug(s). This is getting more and more important because of the increasing threat by multi-resistant bacteria causing severe infections. The IVD MALDI Biotyper System combines the most advanced MALDI-TOF mass spectrometer with the most extensive microbial species library in the market. Bruker continuously invests in bringing the MALDI Biotyper into clinical routine laboratories.

In 2009, the IVD MALDI Biotyper received the CE-mark according to the European IVD directive EC/98/79. Since then Bruker has continuously expanded the species coverage of the system and the geographic coverage of regulatory clearance, thereby adding clinical value for the existing customer base, as well as expanding access by new customers in additional countries. The IVD MALDI Biotyper is now available in most of Europe; in the Americas in Canada, Argentina, Colombia, Ecuador and Mexico; and in the Asia/Pacific region in Japan, China, Hong Kong, Singapore, Taiwan and Australia. Additionally, in November 2013 the MALDI Biotyper CA System received clearance for a first claim by the United States Food & Drug Administration.

About the Bruker MALDI Biotyper

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 reliably and quickly 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 and published studies have highlighted better accuracy and lower cost, as well as typically much faster time-to-result (TTR).

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. In many European and international laboratories the MALDI Biotyper has replaced classical biochemical testing for bacterial identification in recent years due to the accuracy, speed, extensive species coverage, ease of use and cost effectiveness of the system. Classical biochemical techniques depend upon detecting different metabolic properties of microorganisms, and can take hours or even days for analysis, and often lack specificity.

The robust MALDI Biotyper method requires minimal sample preparation and offers low consumables cost. The products of the MALDI Biotyper family are available in a research-use-only (RUO) version, or as the U.S. FDA-cleared MALDI Biotyper CA System, or in an IVD-CE version according to EU directive EC/98/79. The MALDI Biotyper also has medical device registrations in numerous other countries. Work-in-progress RUO versions of the MALDI Biotyper even allow selected high-value antimicrobial resistance tests in translational research.

ABOUT BRUKER CORPORATION (NASDAQ: BRKR)

Bruker is a leading provider of high-performance scientific instruments and solutions for molecular and materials research, as well as for industrial, diagnostics and applied analysis. For more information visit: www.bruker.com.