NG Biotech is a French diagnostics company developing and manufacturing rapid in vitro diagnostic tests. Founded in 2012, it operates industrial sites in Guipry-Messac and markets CE-marked rapid tests globally.
The FDA granted Breakthrough Device Designations to NG-TEST® Candida auris and NG-TEST® Acineto-5®, two rapid assays targeting critical drug-resistant pathogens. Both tests deliver results within 15 minutes and are currently available for Research Use Only while FDA review continues.
The FDA has granted breakthrough device designation to two rapid diagnostic assays from NG Biotech and Hardy Diagnostics targeting Candida auris and carbapenem-resistant Acinetobacter baumannii, both identified as global health priorities by the WHO.
