Feb. 18, 2026—The Food and Drug Administration has granted breakthrough device designation to the NG-Test Candida auris and NG-Test Acineto-5 assays. 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 Diagnostics 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.
Developed and manufactured in France by NG Biotech, the assays are distributed exclusively in the United States by Hardy Diagnostics. They are available for research use only while the FDA review continues.