U.S. Food and Drug Administration (FDA)

NG Biotech and Hardy Diagnostics Secure FDA Breakthrough for AMR Assays

NG Biotech and Hardy Diagnostics have received FDA Breakthrough Device Designation for two rapid diagnostic assays targeting multidrug-resistant pathogens. The NG-TEST Candida auris and NG-TEST Aci assays provide rapid, point-of-care identification of high-priority healthcare-associated infections.