NEW YORK (GenomeWeb) – Australian diagnostics manufacturer Genetic Signatures announced today that it has received CE marking for a PCR-based kit to detect extended spectrum beta-lactamase (ESBL) and carbapenemase-producing organisms (CPOs).
The firm's EasyScreen ESBL & CPO Kit detects strains of antibiotic-resistant pathogens, often referred to as "superbugs," in less than three hours with minimal hands-on time. It detects a total of 16 beta-lactam and carbapenem-resistant pathogen targets.
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.
The firm said it will make the kit available in Europe through a hybrid of direct and distributor-led sales, and is now recruiting a direct sales team in Europe.
This the second Genetic Signatures product group to get CE marking following European approval last year for a suite of enteric pathogen detection assays, including ones for enteric viruses, bacteria, protozoa, and Clostridium difficile.
"This registration follows significant work from the Genetic Signatures team and ultimately reflects the significant potential of our 3base technology to make a real difference in pathogen detection and treatment processes," Genetic Signatures CEO John Melki said in a statement, adding that the approval should further increase the relevance of the company's product suite and sales potential with European customers.