FDA Grants Breakthrough Device Designation to Two Rapid Tests for Critical Drug-Resistant Pathogens
核心洞察
The FDA has granted Breakthrough Device Designations to NG-TEST® Candida auris (搜索) and NG-TEST® Acineto-5® (搜索), two rapid diagnostic assays developed by NG Biotech (搜索) in partnership with Hardy Diagnostics (搜索).
Both tests target WHO-classified critical priority pathogens, delivering results within 15 minutes to address life-threatening conditions and significant unmet medical needs.
NG-TEST® Candida auris (搜索) is the first rapid lateral flow immunoassay specifically designed to identify C. auris with 100% concordance to reference methods.
NG Biotech (搜索), in partnership with Hardy Diagnostics (搜索), announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designations to two rapid diagnostic assays targeting critical drug-resistant pathogens. The NG-TEST® Candida auris (搜索) and NG-TEST® Acineto-5® (搜索) assays represent a major step forward against antimicrobial resistance (搜索), with the FDA designation recognizing technologies that have the potential to address life-threatening conditions and significant unmet medical needs.
Targeting WHO Critical Priority Pathogens
Both diagnostic tests target pathogens classified as critical priorities by the World Health Organization. Candida auris (搜索), listed in the WHO Fungal Priority Pathogens List (2022), is a multidrug-resistant yeast responsible for hospital outbreaks worldwide. The pathogen is often difficult to detect and associated with high mortality rates. Carbapenem-resistant Acinetobacter baumannii (搜索) (CRAB), included in the WHO Bacterial Priority Pathogens List (2024), ranks among the most dangerous hospital-acquired bacteria due to its resistance profile and rapid transmission in healthcare settings.
Revolutionary 15-Minute Detection Technology
NG-TEST® Candida auris (搜索) represents the first rapid lateral flow immunoassay specifically designed to identify C. auris from cultured samples in 15 minutes. Published data demonstrate 100% concordance with reference methods across diverse isolates, supporting its role in outbreak investigation and infection control.
NG-TEST® Acineto-5® (搜索) detects and differentiates five major carbapenemase families—OXA-23-like (搜索), OXA-24/143-like (搜索), OXA-58-like (搜索), VIM (搜索), and NDM (搜索)—directly from Acinetobacter samples, also delivering results within 15 minutes. The PCR-free assay is designed for ease of use without requiring specialized equipment.
Industry Leadership Response
"These breakthrough designations validate both the technology behind our assays and the real-world need they address," said Milovan Stankov-Pugès, CEO of NG Biotech (搜索). Andre Hsiung, Chief Scientific Officer of Hardy Diagnostics (搜索), emphasized that "the designation underscores the growing urgency around rapid detection of multidrug-resistant organisms that pose serious risks in healthcare settings."
Development and Distribution
Developed and manufactured in France by NG Biotech (搜索), the assays are distributed exclusively in the United States by Hardy Diagnostics (搜索). The tests are currently available for Research Use Only while FDA review continues. By accelerating detection of high-risk pathogens, these breakthrough-designated tests aim to strengthen surveillance, guide infection control decisions, and support global efforts to fight antimicrobial resistance (搜索).