April 2026—The Food and Drug Administration has granted breakthrough device designation to the NG-Test Candida auris and NG-Test Acineto-5 assays, which are developed and manufactured in France by NG Biotech and distributed exclusively in the United States by Hardy Diagnostics.
The NG-Test Candida auris is a rapid lateral flow immunoassay designed to identify C. auris from cultured samples in 15 minutes. Published data demonstrate 100 percent concordance with reference methods across diverse isolates, according to a joint press release from Hardy and NG Biotech.
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. Results are provided within 15 minutes.
The assays are available for research use only while under FDA review.
Hardy Diagnostics, 800-266-2222
NG Biotech, +33 (0) 2 23 30 17 83