Diasorin has received de novo authorization from the U.S. Food and Drug Administration (FDA) for its test kit for Candida auris, a multidrug-resistant fungal pathogen common in healthcare settings.
The Simplexa C. auris Direct kit is a real-time polymerase chain reaction assay designed for in vitro qualitative detection of C. auris DNA from an axilla or groin swab taken from patients suspected of having C. auris; it detects the six C. auris clades that are circulating globally. The assay is run on the Liaison MDx system and provides results within two hours, the Saluggia, Italy-based Diasorin said in a statement.
C. auris may infect patients asymptomatically. It spreads easily in hospital and other healthcare settings, and it is a known risk factor for invasive infections with high mortality rates. In addition, C. auris has increasingly become multidrug resistant; the World Health Organization and the U.S. Centers for Disease Control and Prevention have identified C. auris as a fungal pathogen of critical importance.
