NG Biotech, in partnership with Hardy Diagnostics, announces US FDA-granted breakthrough device designations (BDDs) to two rapid diagnostic assays: NG-TEST Candida auris and NG-TEST Acineto-5. The BDD recognizes technologies with the potential to address life-threatening conditions and significant unmet medical needs. NG-TEST Candida auris is a rapid lateral flow immunoassay specifically designed to identify C. auris from cultured samples in 15 minutes. 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.