FDA-Designated AMR Test 2
Detection of WHO-critical drug-resistant fungal/bacterial pathogen
Breakthrough Device DesignationActive
Key Facts
Indication
Detection of WHO-critical drug-resistant fungal/bacterial pathogen
Phase
Breakthrough Device Designation
Status
Active
Company
About NG BIOTECH
NG Biotech is a commercial-stage diagnostics company developing rapid, multiplex tests for critical infectious disease threats, particularly antimicrobial-resistant pathogens. Its core asset is a proprietary immunoassay platform that delivers qualitative results in minutes from small samples like a drop of blood. The company recently gained significant validation with FDA Breakthrough Device Designation for two tests targeting WHO-critical drug-resistant pathogens, positioning it as a key player in the global AMR diagnostic market. With ISO-certified manufacturing facilities in France, NG Biotech serves human health, veterinary, and biodefense sectors.
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