The 15-minute diagnostic assays target Candida auris and carbapenem-resistant Acinetobacter baumannii, both WHO critical priority pathogens.
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designations to two rapid diagnostic tests that detect critical drug-resistant pathogens in healthcare settings, NG Biotech, in partnership with Hardy Diagnostics, announced.
The NG-TEST Candida auris and NG-TEST Acineto-5 assays both deliver results within 15 minutes and target pathogens classified as critical priorities by the World Health Organization (WHO). The FDA’s breakthrough designation recognizes medical technologies that address life-threatening conditions and significant unmet medical needs.
Candida auris, listed in the WHO Fungal Priority Pathogens List in 2022, is a multidrug-resistant yeast that causes hospital outbreaks worldwide and is associated with high mortality rates. Carbapenem-resistant Acinetobacter baumannii, included in the WHO Bacterial Priority Pathogens List in 2024, ranks among the most dangerous hospital-acquired bacteria due to its resistance profile and rapid transmission in healthcare facilities.
Targeting Critical Priority Pathogens
The NG-TEST Candida auris is a rapid lateral flow immunoassay specifically designed to identify C auris from cultured samples. Published data show 100% concordance with reference methods across diverse isolates, supporting its use in outbreak investigation and infection control.
The NG-TEST Acineto-5 detects and differentiates five major carbapenemase families—OXA-23-like, OXA-24/143-like, OXA-58-like, VIM, and NDM—directly from Acinetobacter samples. The PCR-free assay requires no specialized equipment.
“These breakthrough designations validate both the technology behind our assays and the real-world need they address,” says Milovan Stankov-Pugès, chief executive officer of NG Biotech, in a release.
Addressing Healthcare Surveillance Needs
The designations highlight growing concerns about rapid detection of multidrug-resistant organisms in healthcare settings, where delayed identification can compromise patient outcomes and infection control measures.
“The designation underscores the growing urgency around rapid detection of multidrug-resistant organisms that pose serious risks in healthcare settings,” says Andre Hsiung, chief scientific officer of Hardy Diagnostics, in a release.
NG Biotech develops and manufactures the assays in France, while Hardy Diagnostics serves as the exclusive US distributor. Both tests are currently available for research use only while FDA review continues.
The tests aim to strengthen surveillance capabilities, guide infection control decisions, and support global antimicrobial resistance efforts by accelerating detection of high-risk pathogens that traditional methods may take hours or days to identify.
Photo caption: NG-TEST Candida auris and NG-TEST Acineto-5 assays
Photo credit: NG Biotech / Hardy Diagnostics
