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Bruker Corporation. (4/24/14). "Press Release: Bruker Daltonics Inc. Announces U.S. Regulatory Milestone". Billerica, MA.

Region Region United States (USA)
Organisations Organisation Bruker Daltonics Inc.
  Group Bruker Corporation (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Products Product MALDI Biotyper CA system
  Product 2 clinical research
Person Person Goedesky, George (Bruker 201009 Exec Director Marketing + BusDev MALDI Biotyper)
     


Bruker Daltonics, Inc. is pleased to announce that its second clinical trial for the MALDI Biotyper in the United States is now well under way with an expanded group of clinical trial sites.


Since its European launch in 2007, the MALDI Biotyper has revolutionized microbiology testing by providing identification results in minutes versus hours or days for phenotypic methods. The high-throughput MALDI Biotyper CA System can identify 192 isolates in about an hour with a decentralized workflow common to microbiology laboratories, and it can do so at reasonable cost, thus improving productivity. In published studies, considerable cost reductions of 56 - 89% have been demonstrated through reduction in phenotypic kit usage. Over 1,100 microbiology laboratories worldwide have selected Bruker as their supplier of MALDI-TOF systems for microbiology testing with over 200 systems sold in the Americas to date.

Previously, Bruker Daltonics had received 510(k) clearance for the MALDI Biotyper CA System from the US FDA in November 2013. This clearance included Bruker's global market leading MALDI Biotyper instrumentation, IVD reagents, software, standard operating procedures, and an initial library of over 100 species of aerobic gram negative bacteria contained within 40 species or complexes. Results generated by the MALDI Biotyper CA System were compared to 16s molecular sequencing and showed 99.78% of the isolates tested produced correct identifications to the genus or species level with only 0.09% of isolates unable to be identified. This level of accuracy is the highest seen to date for any MALDI-TOF-based bacterial identification system. In comparisons done to date, this gram negative library represents over 98% of a typical clinical laboratories aerobic gram negative workflow.

Data from this second clinical trial are expected to be used in further regulatory submissions in mid-2014, highlighting the company's commitment to make additional high-quality results available to patients and customers in the USA. This second clinical trial is intended to expand our current US clinical microbiology offer with additional rare gram negative bacteria, as well as with aerobic gram positive bacteria, yeasts, and anaerobic microorganisms cultured from human specimens.

Mr. George Goedesky, Bruker Daltonics US Vice President for Microbiology, stated: "Over 180 additional species are being included in this US clinical trial and we are pleased with the progress made to date. Over 330 peer-reviewed publications using the Bruker MALDI Biotyper have demonstrated the operational cost effectiveness, accuracy, and reductions in time to result (TTR). These advantages offer clinical microbiology laboratories a useful tool to meet today's challenges while assisting the clinician with better, more accurate and timely information."

Further details can be found at. https://www.clinicaltrials.gov/ct2/show/record/NCT02098226?term=bruker&rank=1


About the MALDI Biotyper

Bruker's proprietary MALDI Biotyper product family enables molecular identification, taxonomical classification, or de-replication 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. Applications include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product processing, and quality control, as well as marine microbiology. Bruker's robust MALDI Biotyper method requires minimal sample preparation and offers low consumables cost per sample. The MALDI Biotyper is available in a Research Use Only (RUO) version, as well as in an IVD-CE version according to EU directive EC/98/79 in certain European countries. The MALDI Biotyper CA System received US FDA 510(k) clearance in November 2013. For more information: www.maldibiotyper.com


Media Contact:

George Goedesky
Vice President, MALDI Biotyper
Bruker Daltonics Inc.
T: +1 (812) 844-7282
E: george.goedesky@bruker.com

   
Record changed: 2016-01-10

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