Expanded Pathogen Identification Receives FDA Clearance

Mycobacteria, Nocardia and molds are complex organisms to identify, requiring days or weeks of specific culture conditions for appropriate growth and subsequent advanced methods for reliable identification to the species level.

A newly expanded database, now offers simple, rapid, safe and reliable identification of these medically important pathogens, providing clinicians with actionable results to better manage these infections, such as tuberculosis, lung and bone infections, and other serious organ infections.

This database includes more than 15,000 distinct strains to provide extremely high accuracy and, for the first time, 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 VITEK MS, Matrix Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) Mass Spectrometry System for rapid pathogen identification, has received 510(k) clearance from the US Food and Drug Administration for the expanded identification of mycobacteria, Nocardia and molds.

To gain new FDA clearance for these new species, bioMérieux submitted data from a multi-center study consisting of 2,695 clinical isolates for 47 molds, 19 mycobacteria, and 12 Nocardia. The FDA clearance of Mycobacterium species was from both solid and liquid growth media. The VITEK MS system’s newly expanded database and Mycobacterium/Nocardia and Molds reagent kits are now commercially available in the USA.

In cases where microorganisms are resistant to carbapenems (a very broad spectrum antibiotic class), bioMérieux has also developed and received FDA 510(k) clearance for its RAPIDEC CARBA NP test that enables the detection of carbapenemase producers within two 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.

François Lacoste, DVM, bioMérieux Corporate VP, Clinical Unit, said, “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 customers in the USA with additional features for the already well adopted VITEK MS rapid identification system. 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.”