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bioMérieux Announces U.S. FDA Clearance for VITEK® MS


bioMérieux 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 50(th) 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."

"Hackensack University Medical Center remains committed to staying at the forefront of new technology and treatment methods to better care for our patients, and the VITEK® MS is another example of this commitment, " said Robert C. Garrett, president and chief executive officer of Hackensack University Health Network. "We're conducting a study to see what benefits accrue from diagnosing and treating patients with infectious disease faster and more accurately. Mistreatment and antibiotic overuse are major problems in our healthcare system. They cause prolonged suffering and are very costly. We think VITEK® MS, by diagnosing patients faster and allowing for more rapid treatment, should help our bottom line by reducing our expenditures on medication and reducing the length of stay of patients with serious infections."

The VITEK® MS database represents the vast majority of bacterial and fungal infections that afflict humans. As the world leader in clinical microbiology, bioMérieux, holds the largest private strain collection in the world.

For microbiologists who choose mass spectrometry for microbial identification, bioMérieux offers integrated workflow solutions with its VITEK® 2 system to ensure optimal user convenience, full sample traceability and quality of results. All of bioMérieux's systems will be managed with Myla® web-based laboratory informatics solution. The fully integrated system will provide the rich connectivity between identification with VITEK® MS and antibiotic sensitivity testing with VITEK® 2, enhanced information and workflow management.

The following is an FDA press release announcing the 510(k), dated August 14, 2013:


"The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans. The VITEK MS can identify 193 different microorganisms and can perform up to 192 different tests in a single automated series of testing, with each test taking about one minute.

The VITEK MS can identify yeasts such as those from the Candida, Cryptococcus and Malassezia groups, and bacteria from the Staphylococcaceae, Streptococcaceae, Enterobacteriaceae, Pseudomonadaceae, and Bacteroidaceaefamilies, which are associated with skin infections, pneumonia, meningitis, and bloodstream infections. People with immune systems that are compromised or weakened by HIV/AIDS, cancer treatment, or anti-rejection therapy following an organ transplant are particularly vulnerable to these infections.

“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.”

The VITEK MS incorporates a technology called matrix-assisted laser desorption/ionization–time of flight mass spectrometry (MALDI-TOF MS). The technology uses a laser to break yeast and bacteria specimens into small particles that form a pattern unique to the microorganism. The VITEK MS automatically compares the microorganism pattern to 193 known yeasts and bacteria in the test system’s database to identify the microorganism.

Compared to other identification methods that require abundant organism growth for testing, mass spectrometry requires only a small amount of yeast or bacterial growth, so testing can start as soon as growth is visible, generally within 18 to 24 hours.  Traditional methods can take up to five days to produce the same identification results.

The FDA reviewed the VITEK MS through its de novo classification process, a regulatory pathway for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device.

For the de novo petition, the FDA based its decision on the results of a study of 7,068 microorganisms. When compared to sequencing and biochemical testing, the VITEK MS correctly identified the scientific group or family 93.6 percent of the time (with 87.5 percent of microorganisms identified to species level). The VITEK MS provided a `‘no identification’` result for 3.2 percent of the microorganisms in the study. Of all test results, only 0.8 percent were incorrect and 2.4 percent were low discrimination with no correct result.

The VITEK MS is for clinical use for the identification of microorganisms cultured from human specimens. It is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections."

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