BILLERICA. Mass.—Bruker Corporation today announced that it has been granted U.S. FDA clearance under Section 510(k) to market its MALDI Biotyper CA System in the United States for the identification of Gram negative bacterial colonies cultured from human specimens.
Bruker has conducted a multi-site clinical trial comparing performance of the MALDI Biotyper CA System to 16S ribosomal RNA gene sequencing. The overall accuracy of the MALDI Biotyper CA System was comparable to that of nucleic acid sequencing. FDA clearance of the MALDI Biotyper CA System is the latest achievement in Bruker's continuous efforts to develop MALDI-TOF mass spectrometry into the most advanced platform for clinical microbiology identification.
In 2009, Bruker launched a MALDI Biotyper system in compliance with the European in vitro diagnostic directive EC/98/79, making the CE-IVD labelled IVD-MALDI Biotyper the first MALDI-TOF-based product registered for use in European clinical microbiology laboratories. Since then, Bruker has continued its effort to expand into routine clinical microbiology and other markets throughout the world. Currently the CE-IVD labelled IVD-MALDI Biotyper is available for clinical microbiology routine usage in Europe, as well as in many countries around the world, including Canada, Argentina, Mexico, Colombia and Ecuador in the Americas and in Japan, Hong Kong, Singapore, Malaysia and Taiwan in Asia/Pacific.
Frank Laukien, president and CEO of Bruker Corporation, commented: "We are very excited about this major milestone in our effort to introduce MALDI-TOF mass spectrometry into clinical diagnostics. For the last seven years Bruker has been working on continuous innovation in the field of MALDI-TOF-based microbial identification, bringing the MALDI Biotyper platform into clinical routine laboratories. The MALDI Biotyper has been a success with more than 1,000 systems sold or leased worldwide, which has positively affected the health of many patients. Bruker has initiated a continuing revolution in clinical microbiology towards the MALDI Biotyper as a next-generation identification technique. With clearance by the U.S. FDA to market the MALDI Biotyper CA System, we expand our market reach into the largest clinical market in the world, with expected significant improvements in outcomes and reductions in the cost of healthcare."
Dr. Robert Jerris, the director of clinical microbiology at the Children´s Healthcare of Atlanta pediatric hospital, added: "MALDI-TOF has had a dramatic impact on patient care at Children's Healthcare of Atlanta. The ability to identify organisms directly from plates – saving at minimum a day over conventional phenotypic tests for many organisms – has impacted therapy, timely infection control and contributed to decreases in healthcare expenditures. Outcome studies have shown such significant positive results that it is predictable to say that this technology will eventually be a staple in clinical microbiology."
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 the greater accuracy and lower cost offered, as well as the typically much faster time-to-result.
Applications of the various MALDI Biotyper solutions 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 European and international laboratories the MALDI Biotyper has replaced classical biochemical testing for bacterial identification in the past five 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; however, these techniques can take hours or even days for completion and they 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, 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.
The MALDI Biotyper CA System includes the bench-top microflex TM MALDI-TOF (matrix-assisted laser desorption ionization time-of-flight) mass spectrometer, software, IVD labeled reagents, a 48-spot MALDI target and a library of microorganism reference spectra.
Source: Bruker Corporation