FDA Grants Breakthrough Device Status to NG Biotech and Hardy Diagnostics for Two Rapid Pathogen Tests
NG Biotech, in collaboration with Hardy Diagnostics, has received Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA) for two innovative diagnostic tests: NG-TEST® Candida auris and NG-TEST® Acineto-5®.
These designations are reserved for technologies that address critical medical needs and potentially life-threatening conditions.
Both assays focus on pathogens identified as high-priority threats by the World Health Organization (WHO).
Candida auris is a multidrug-resistant yeast associated with hospital outbreaks and significant mortality rates, while carbapenem-resistant Acinetobacter baumannii (CRAB) is a highly transmissible bacterium in healthcare settings that shows resistance to multiple antibiotics.
The NG-TEST® Candida auris is a rapid lateral flow test that can detect C. auris from cultured samples in just 15 minutes, demonstrating complete agreement with standard reference methods.
The NG-TEST® Acineto-5® test identifies and differentiates the five main carbapenemase families directly from Acinetobacter samples within the same short timeframe, without the need for PCR or specialized laboratory equipment.
Both tests are developed and manufactured in France by NG Biotech and are distributed exclusively in the U.S. by Hardy Diagnostics. Currently, they are available for Research Use Only.
These FDA breakthrough-designated tests aim to enhance the rapid identification of high-risk pathogens, strengthen infection monitoring, support outbreak management, and aid global efforts to combat antimicrobial resistance.
