NEW YORK (GenomeWeb News) – The US Food and Drug Administration said yesterday that it has granted BioMérieux's Vitek MS clinical microbiology mass spectrometry system 510(k) de novo clearance.
The system, which uses MALDI-TOF mass spec to identify disease-causing organisms including bacteria and yeast, is the first such platform cleared for clinical use in the US. The Vitek MS identifies microbes by matching the protein profiles of sample organisms generated via MALDI mass spec to profiles contained in a proprietary database.
Compared to traditional biochemical methods of microbe detection, MALDI-based platforms like the Vitek MS can offer improvements in speed, price, and accuracy. According to BioMérieux, the Vitek MS can identify 193 different microorganisms and can perform up to 192 different tests in a single automated run. Each test takes about one minute, compared to hours or days for conventional methods.
"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," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at FDA's Center for Devices and Radiological Health, said in a statement. "Rapid identification of harmful microorganisms can improve the care of critically ill patients."
For its 510(k) application, BioMérieux submitted data from a multi-center study consisting of 7,068 clinical isolates. The Vitek MS platform's accuracy was compared to 16S Ribosomal RNA gene sequencing, the current 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 the Vitek MS compared to nucleic acid sequencing for these organisms was 93.6 percent, the company said.
BioMérieux's main competitor in the space, Bruker, has likewise made a 510(k) submission for its competing MALDI Biotyper clinical microbiology platform, and is awaiting a ruling from FDA. Both companies' devices have the CE-IVD Mark in Europe and are available there for clinical use.
According to BioMérieux, the Vitek MS is also approved for clinical use in China as well as a number of additional Asian and Latin American countries, while Bruker's Biotyper is also approved for clinical use in Australia, New Zealand, Taiwan, and Japan.
There are roughly 800 Biotypers installed worldwide, versus around 400 Vitek MS units.