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.
NG-TEST Candida auris is a rapid lateral flow immunoassay developed to identify the yeast from cultured samples in 15 minutes.
Included in the Bacterial Priority Pathogens List, Carbapenem-resistant Acinetobacter baumannii (CRAB) can rapidly transmit within healthcare environments.
Published studies show a 100% concordance with reference methods across multiple isolates, supporting its utility in outbreak response and infection control efforts.
NG-TEST Acineto-5 detects and differentiates five major carbapenemase families, oxacillinase-24 (OXA-24)/143 -like, OXA-23-like, verona integron-encoded metallo-beta-lactamase (VIM), OXA-58-like, and New Delhi metallo-beta-lactamase (NDM), from Acinetobacter samples and delivers results within 15 minutes.
This assay operates without polymerase chain reaction or specialised equipment, streamlining laboratory workflows.
NG Biotech developed and manufactured the assays in France, with Hardy Diagnostics serving as the exclusive distributor in the US. Both tests are available for research use only, pending ongoing FDA review.
NG Biotech CEO Milovan Stankov-Pugès said: “These breakthrough designations validate both the technology behind our assays and the real-world need they address.”
Hardy Diagnostics' chief scientific officer Andre Hsiung said: “The designation underscores the growing urgency around rapid detection of multi-drug-resistant organisms that pose serious risks in healthcare settings.”
