FDA has recently granted premarket notification (510(k)) clearance to the Vitek MS matrix-assisted laser desorption ionization–time of flight (MALDI-TOF) mass spectrometry system by bioMerieux, Marcy l’Étoile, France, for the expanded identification of mycobacteria, nocardia, and molds.
The Vitek MS database includes more than 15,000 distinct strains and enables the safe identification of the Mycobacterium tuberculosis (TB) group, the most frequent non-tuberculous mycobacteria (NTM), nocardia, and the most medically important molds. The system’s newly expanded database and mycobacteria, nocardia, and molds reagent kits are now commercially available in the United States.
Mycobacteria, nocardia, and molds are difficult organisms to identify, requiring days or weeks of specific culture conditions for appropriate growth and subsequent advanced methods for reliable identification at the species level. With its newly expanded database, bioMérieux’s Vitek MS system now offers simple, rapid, safe, and reliable identification of medically important pathogens, providing clinicians with actionable results to better manage such infections as tuberculosis, lung and bone infections, and other serious organ infections.
To gain FDA clearance for the new species, bioMérieux submitted data from a multicenter study consisting of 2,695 clinical isolates for 47 molds, 19 mycobacteria, and 12 nocardia. FDA’s clearance of mycobacterium species was from both solid and liquid growth media.
“We are honored to receive the first 510(k) clearance from the FDA for the identification of mycobacteria, nocardia, and molds on a MALDI-TOF system, and to provide our US customers with additional features for the already well adopted Vitek MS rapid identification system,” says François Lacoste, corporate vice president for the bioMérieux clinical unit. “As the world leader in microbiology, one of our priorities is to continuously develop high medical value solutions that enable rapid and accurate detection of important microorganisms, with the ultimate goal of improving patient care.”
Vitek MS is part of bioMérieux’s line of diagnostics for infectious disease/antimicrobial susceptibility testing (ID/AST). Together, Vitek MS for identification and Vitek 2 for antimicrobial susceptibility testing provide the integration and flexibility needed to optimize laboratory workflow and support appropriate antimicrobial treatment decisions. The combination of Vitek MS and Vitek 2 provides confidence in reporting results, with speed and accuracy for routine diagnoses, unusual or resistant organisms, or critical clinical situations.
For cases where microorganisms are resistant to carbapenems (a broad-spectrum antibiotic class), bioMérieux has developed and received FDA 510(k) clearance for its RapidEC Carba NP test, which enables the detection of carbapenemase producers within 2 hours. RapidEC Carba NP helps health professionals make vital treatment decisions and facilitates implementation of infection prevention and control measures. These highly complementary solutions help improve antibiotic stewardship in the fight against antimicrobial resistance.
For further information, visit bioMérieux.