In a major step forward against antimicrobial resistance (AMR), NG Biotech, in partnership with Hardy Diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designations to two rapid diagnostic assays: NG-TEST Candida auris and NG-TEST Acineto-5.
Both tests target pathogens classified as critical priorities by the World Health Organization (WHO).
NG-TEST Candida auris is 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 detects and differentiates five major carbapenemase families—OXA-23-like, OXA-24/143-like, OXA-58-like, VIM, and NDM—directly from Acinetobacter samples, also delivering results within 15 minutes. The PCR-free assay is designed for ease of use, without specialized equipment.
Developed and manufactured in France by NG Biotech, the assays are distributed exclusively in the United States by Hardy Diagnostics. They are currently available for Research Use Only while FDA review continues.
Read more at Hardy Diagnostics
Read more at NG Biotech
