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Bruker Announces Improved Solutions for Microbial Strain Typing, Hospital Hygiene and Infection Control, and Candida auris Testing at ASM 2018

June 07, 2018

- Improved IR Biotyper™ system for fast, routine and cost-effective strain typing for hospital infection control and earlier detection of outbreaks
- FDA clearance for Candida auris identification with the MALDI Biotyper® to support better diagnostics and monitoring in critically ill patients

ATLANTA, June 7, 2018 /PRNewswire/ -- At the American Society for Microbiology (ASM) Microbe 2018 meeting (www.asm.org), Bruker announces improved solutions for microbial strain typing, hospital hygiene and infection control.

Figure 1: Dr. Stefan Zimmermann, Department of Medical Microbiology and Hygiene at the University Hospital Heidelberg, Germany

The bench-topIR Biotypersystem for microbial strain typing is based on Fourier-Transform Infrared (FTIR) spectroscopy technology, and complements Bruker's world-leadingMALDI Biotypermass spectrometry platform for fast microbial identification from cultures using protein fingerprinting. TheIR Biotyperuses many classes of biomolecules, like lipids, proteins, nucleic acids and polysaccharides simultaneously to characterize a microbial sample by strain-specific absorbance patterns in the infrared spectrum. This makes theIR Biotyperan efficient tool for fast and cost-effective strain typing. TheIR Biotypercan be used stand-alone for routine hospital hygiene and infection control, or can be combined in a workflow with parallel microbial species identification by theMALDI Biotyper.Due to its fast time-to-result (TTR), excellent strain differentiation performance, low cost per sample, ease of use, robustness and throughput, theIR Biotypercan perfectly complement next-generation sequencing (NGS) strain typing, which typically requires more time, training and infrastructure in core labs.

TheIR Biotyperis easy to use without any prior knowledge of FTIR technology. Its workflow uses colonies from an agar plate, typically after overnight incubation. The assay needs only minimal hands-on time supported by theIR Biotyper Kitthat allows standardized and straight-forward sample preparation, and contains proprietary test standards for quality control. Each sample is measured in a few minutes. TheIR Biotypersoftware offers a simple user interface for the set-up of automated, unattended runs. The software also includes data interpretation with optimized statistical algorithms and provides clear visualization of the results, for example, as a distance matrix, or as a dendrogram of multiple isolates. The newIR Biotyper2.0 software now offers further enhanced bioinformatics capabilities via novel algorithms, connectivity to external expert systems via data export functions, and improved data visualization.

With its easy, user-friendly workflow, fast turn-around time and cost-effective sample preparation, theIR Biotyperenables new in-house workflows in hospital infection control. More samples can be analyzed prospectively in less time and at a lower cost compared to molecular technologies in hygiene laboratories. Results are generated directly after the measurements. This also improves sample logistics as many samples that previously had to be sent to central core molecular testing facilities can now be analyzed directly in the hospital hygiene laboratory. TheIR Biotyperis for research-use-only and not for diagnostic use. Two scientific posters showing the performance of theIR Biotyperin an outbreak analysis and for the detection of virulence factors in the zoonotic pathogenArcobacter butzleriwill be presented at this ASM Microbe meeting.

Dr. Stefan Zimmermann, Department of Medical Microbiology and Hygiene at the University Hospital Heidelberg, Germany, stated: "We have implemented theIR Biotypersince several months in our laboratory. TheIR Biotyper已经证明是一种很有前途的工具,快速和rel吗iable outbreak analysis. In our hands, it showed good concordance with previous typing methods, like pulse-field gel electrophoresis and RAPD-PCR. Its easy handling and short time to result enables routine screening and outbreak prevention. Moreover, the cost-efficientIR Biotyperapproach enables research projects in epidemiology with large sample cohorts that previously were not feasible in practice. In addition, we envision further applications like the detection of virulent strains in the future."

Bruker recently received clearance from the U.S. Food and Drug Administration for the identification ofC. auris(www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605336.htm) on theMALDI Biotyper CAsystem.Candida aurisis a yeast species that increasingly causes fungal infections in critically ill hospital patients. It can cause blood stream infections, urinary tract infections and wound infections. Treatment can be complicated because it can easily be misidentified as otherCandidaspecies by traditional methods.C. aurisis frequently multidrug-resistant and has caused several outbreaks in healthcare settings.

C. auriswill be added to the MBT CA system's cleared reference library, which now contains 334 species or species groups, covering 425 clinically relevant bacteria and yeast species. According to the FDA press release, this is "the first test to identify the emerging pathogenCandida auris, which can cause serious infections in hospitalized patients." TheC. aurisidentification by a FDA-cleared method does not only help individual patients with an important diagnosis, but it enables direct screening and hygiene measures in order to prevent further spreading of the organism.

Dr. Wolfgang Pusch, Executive Vice President for Microbiology & Diagnostics at Bruker Daltonics, commented: "It is a proven strength of theMALDI Biotypersystem and identification algorithms that emerging pathogens, such asCandida auris, can easily be added to its reference library. We are very pleased with this early clearance of theC. aurisclaim by the FDA in order to make this significant improvement available to the US healthcare system relatively quickly."

About the BrukerMALDI Biotyper(MBT) Platform
TheMALDI Biotyperfamily of systems enables molecular identification 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. TheMALDI Biotyperuses a molecular approach based on specific proteomic fingerprints. Many published studies have highlighted its greater accuracy and lower cost, as well as typically much faster time-to-result (TTR).

Applications include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety and quality control, as well as marine microbiology. In many laboratories theMALDI Biotyperhas replaced classical biochemical testing for bacterial identification due to the accuracy, speed, extensive species coverage, ease of use and cost effectiveness of the system. Traditional biochemical techniques detect different metabolic properties of microorganisms, can take many hours or even days for completion, and they often lack specificity.

The robustMALDI Biotyperrequires minimal sample preparation and offers low consumables cost. The products of theMALDI Biotyperfamily are available in a research-use-only (RUO) version, as the U.S. FDA-clearedMALDI Biotyper CA System, or in an IVD-CE version according to EU directive EC/98/79. TheMALDI Biotyperalso has medical device registrations in numerous other countries. RUO versions of theMALDI Biotyperallow selected, high-value antimicrobial resistance tests.

About the BrukerIR BiotyperPlatform
TheIR Biotyperis a benchtop FTIR spectroscopy system for hospital hygiene and infection control applications. It used the absorption of infrared light by biomolecules, as infrared light induces vibrations and rotations of covalent bonds in biomolecules. Using this principle, theIR Biotypersimultaneously analyses various classes of biomolecules, such as peptides, proteins, carbohydrates and lipids. The resulting spectrum is a molecular fingerprint of the cellular content. This allows robust differentiation between microbial isolates. After an identification of the microbial species with theMALDI Biotyper, theIR Biotyperallows for rapid, cost-effective typing of strains.

应用包括scen疫情分析arios in hospital hygiene and epidemiology, as well as root cause analysis in microbial food contamination. TheIR Biotyperoffers low consumables cost, and requires minimal sample preparation. Starting from an isolated culture on an agar plate, a cell suspension is prepared and an aliquot is deposited on the sample plate and air dried. The measurement itself takes a few minutes. After microbial cultivation, theIR Biotyperallows for quick onsite analysis in the hygiene monitoring laboratory, which compares very favorably with the cost and turn-around time to send samples for molecular testing. TheIR Biotyperis for research-use-only (RUO) in hygiene, infection control and epidemiology.

About Bruker Corporation (NASDAQ: BRKR)
Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker's high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology. For more information, please visit:www.fatactor.com.

Investor Contact:
Miroslava Minkova
Director, Investor Relations & Corporate Development
T: +1 (978) 663–3660, ext. 1479
E:[email protected]

Contact for Media and Customers:
Dr. Wolfgang Pusch
Executive Vice President for Microbiology & Diagnostics
Bruker Daltonics Division
Tel: +49-421-2205-270
E:[email protected]

Figure 2: The IR Biotyper System

Figure 3: The IR Biotyper Kit

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