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bioMérieux Announces U.S. FDA Clearance for VITEK® MS, a Revolutionary Technology Which Reduces Microbial Identification from Days to Minutes
Date:8/21/2013

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 Washing
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