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Durham, North Carolina (PRWEB) August 21, 2013 -- bioMérieux today announced that it has been granted U.S. FDA 510(k) de novo clearance for VITEK® MS, the first clinical mass spectrometry MALDI-TOF-based system available in the U.S. for rapid identification of disease-causing bacteria and yeast. VITEK® MS is the latest addition to the VITEK® family of products, and it is the first system to enable detection of disease causing microorganisms in minutes: this game-changing technology can significantly improve patient care. The Cleveland Clinic recently named the technique as one of the Top Ten Breakthrough Medical Technologies of 2013.
“bioMérieux has a long history of bringing the most innovative technology to the world of microbiology, so as a world leader in clinical microbiology, we are very proud to be the first to introduce mass spectrometry to U.S. clinical laboratories in 2013, as we celebrate the Company’s 50th anniversary,” said Alexandre Mérieux, Directeur Général Délégué and Vice President, Microbiology Unit. “For half a century, bioMérieux has introduced pioneering diagnostic innovations to the clinical laboratory and VITEK® MS is part of our commitment to transform microbiology diagnostics with innovative solutions providing actionable information for improved medical decisions.”
“The ability for laboratories to use one device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at FDA’s Center for Devices and Radiological Health. “Rapid identification of harmful microorganisms can improve the care of critically ill patients.”
To gain FDA clearance bioMérieux submitted data from a multi-center study consisting of 7,068 clinical isolates. VITEK® MS accuracy was compared to 16S Ribosomal RNA gene sequencing, the gold standard, for the following categories of microbial pathogens: anaerobic bacteria, Enterobacteriaceae, Gram-positive aerobes, fastidious Gram-negative bacteria, Gram-negative non-Enterobacteriaceae and yeast. The overall accuracy of VITEK® MS compared to nucleic acid sequencing for these organisms was 93.6 percent.
Scientists from these investigation sites praised the new technology and its potential to improve public health:
“In the battle with infectious diseases, time is a luxury we don’t have. MALDI-TOF will have one of the greatest impacts on Clinical Microbiology since the use of molecular amplification methods for the identification of pathogens,” said Christine C. Ginocchio, Ph.D., M. T. (ASCP), Senior Medical Director and Chief, Division of Infectious Disease Diagnostics, North Shore-LIJ Health System Laboratories and Professor Hofstra North Shore-LIJ School of Medicine. “This technology will revolutionize how we approach traditional microbial identification. Combined with rapid antimicrobial susceptibility testing we can now provide a diagnosis and treatment options within a time frame that will reduce morbidity and mortality.”
Researchers from the Washington University School of Medicine decided to put VITEK® MS to a very rigorous test by analyzing a ten-year collection of clinical samples which was initially difficult to identify with traditional methods.
“The question was, if we tested these organisms with MALDI-TOF MS how would we do?” said Dr. Carey-Ann Burnham, Assistant Professor of Pathology and Immunology at Washington University School of Medicine and the Medical Director of Microbiology at Barnes Jewish Hospital. “So, we pulled these samples from the freezer and the answer was very exciting. Nearly all of the isolates were able to be identified with high accuracy in a matter of moments using a single method: MALDI-TOF MS.”
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