Expanding the ability to identify pathogens on VITEK® MS

BioMérieux receives FDA approval to expand pathogen identification on VITEK® MS

BioMérieux receives FDA approval to expand pathogen identification on VITEK® MS

Marcy l'Étoile - 31 July 2017 - bioMérieux, a pioneer in the field of in vitro diagnostics, has announced that the MALDI-TOF1 VITEK® MS mass spectrometer system has received the 510(k) certification of U.S. Food and Drug Administration (FDA) expanded scope for identification of bacteria Mycobacteria, Nocardia, and molds. This database includes more than 15,000 distinct strains to provide extremely high accuracy, and allows for the first time to safely identify the group Mycobacterium tuberculosis (TB), and other common Mycobacteria (NTM), Nocardia and the most important medically mold. The newly expanded database system and VITEK® MS Mycobacterium/Nocardia and mold test kits are now on the market in the United States.

Mycobacteria, Nocardia and molds are complex organisms to identify, requiring several days or weeks along with specific culture conditions for proper growth and subsequent advanced methods for information identification. depend on species level. With an expanded new database, bioMérieux's VITEK® MS system now provides fast, secure and reliable formatting for these important pathogens.

To achieve new FDA clearance for these new species, bioMérieux submitted data from a multicenter study that included  2,695 clinical isolates for 47 molds, 19 bacteria, and 12 Nocardia. FDA certification for Mycobacterium strains in both solid and liquid cultures.

"We are honored to receive the first 510(k) certification from the FDA for the identification of mycobacteria, Nocardia and molds on the MALDI-TOF system and to provide our customers with additional features for the MALDI-TOF system. fast and accurate identification system -VITEK® MS", said François Lacoste, deputy director of bioMérieux. "As a pioneer in the field of microbiology, it is our priority to continuously develop solutions of high medical value that enable the rapid and accurate detection of important microorganisms with the ultimate goal of ultimately improving patient care."

VITEK® MS is one of bioMérieux's comprehensive and complementary ID/AST solutions for infectious disease diagnostics. Together, VITEK® MS for identification and VITEK® 2 for antibiotic susceptibility testing provide the integration and flexibility needed to optimize laboratory workflows and support appropriate antibiotic 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 important clinical situations important.

BioMérieux's comprehensive solution

For microorganisms resistant to carbapenems (broad-spectrum antibiotics), bioMérieux has also developed and received FDA 510(k) certification for the RAPIDEC® CARBA NP test allowing the detection of carbapenemase-producing strains within two hours. RAPIDEC® CARBA NP helps healthcare professionals make important treatment decisions and facilitates the implementation of infection prevention and treatment measures. These complementary solutions help improve antibiotic management in the fight against antibiotic resistance.