NEW YORK (GenomeWeb) – Australian molecular diagnostics firm Genetic Signatures said on Tuesday it has received regulatory approval in that country to market its detection kit for antibiotic-resistant pathogens.
The firm received Therapeutic Goods Administration registration for the sale of its Extended Spectrum Beta-Lactamase and Carbapenemase Producing Organisms Detection Kit, following CE-IVD marking for the kit last month. It detects antibiotic-resistant pathogens in less than three hours with minimal hands-on time for laboratory technicians and is designed to provide rapid detection of 16 beta-lactam and carbapenem-resistant pathogen targets, according to Genetic Signatures.
The assay relies on the firm's 3base technology, a method using bisulfite conversion to reduce complexity in nucleic acid samples in order to improve specificity and sensitivity.
Genetic Signatures is based in New South Wales and develops real-time PCR-based products for the routine detection of infectious diseases under the EasyScreen brand. The 3base technology provides high-volume hospital and pathology labs the ability to screen for infectious pathogens with high specificity in a rapid throughput environment, it said.