The FDA cleared the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalized patients.
The FDA permitted marketing for a new use of the MALDI Biotyper CA system (Bruker Daltonik GmbH) for the identification of C. auris, adding to the system’s already cleared uses for the identification of 333 species or species groups, covering 424 clinically relevant bacteria and yeast species. The Biotyper CA system is only available in the United