NG Biotech and Hardy Diagnostics have received the US Food and Drug Administration (FDA) breakthrough device designation for two rapid diagnostic assays, NG-TEST Candida auris and NG-TEST Acineto-5, targeting critical drug-resistant pathogens.

The designation applies to assays for pathogens, specifically targeting Candida auris and Acinetobacter baumannii, which are identified by the World Health Organization (WHO) as global health priorities.

Candida auris is listed in the WHO’s Fungal Priority Pathogens List and is a multi-drug-resistant yeast responsible for hospital outbreaks with challenging detection and high mortality rates.