Two New Rapid Tests

FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens

February 18, 2026
1:13 pm

SANTA MARIA, Calif. and GUIPRY, France, Feb. 18, 2026 /PRNewswire/ -- In a major step forward against Antimicrobial Resistance (AMR), NG Biotech, in partnership with Hardy Diagnostics, announced today 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®. The designation recognizes technologies with the potential to address life-threatening conditions and significant unmet medical needs.

Both tests target pathogens classified as critical priorities by the World Health Organization (WHO). Candida auris, listed in the WHO Fungal Priority Pathogens List (2022), is a multidrug-resistant yeast responsible for hospital outbreaks worldwide. It is often difficult to detect and associated with high mortality. Carbapenem-resistant Acinetobacter baumannii (CRAB), included in the WHO Bacterial Priority Pathogens List (2024), is among the most dangerous hospital-acquired bacteria due to its resistance profile and rapid transmission in healthcare settings.

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.

FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens

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