Bruker Corporation (NASDAQ: BRKR) 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.
The MALDI Biotyper CA System includes the bench-top microflex™ 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. 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 Chief Executive Officer 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 US 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, PhD, D (ABMM), 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 decrease 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."
SOURCE BRUKER CORPORATION