Direct species-specific ID & AST from urine and whole blood clinical samples
Species-specific identification and comprehensive susceptibility results were dependent on overnight culture followed by sub-culture techniques on plated media, and each step required at least one day, advances in technology, particularly molecular techniques, have changed the picture significantly. Molecular diagnostic assays are now available for direct testing of positive blood cultures, providing more timely ID results. These tests detect multiple ID targets, characterizing >80% of positive blood cultures and providing accurate pathogen ID. Some systems additionally, such as the T2 Bacteria® Panel, which is cleared by FDA and CE Marked in the EU, identifies six of the most deadly and prevalent bacteria species that are often not covered by empiric therapy directly from whole blood samples. However, it does not provide either AST or resistance gene detection. A sub-culture for AST is still required as indicated in product label for managing effective antimicrobial therapy as shown below.
RUO robotic ID/AST systems (BsiMax®, NicuMax®, UtiMax®)
GeneFluidics’ current commercialization effort and regulatory approaches focus on avoiding unnecessary and inappropriate antibiotic use with a robotic system to perform direct sample-to-result pathogen identification (ID) in as short as 45 minutes (UtiMax®) and antimicrobial susceptibility testing (AST) in as short as 150 minutes (ProMax®). GeneFluidic’ third device, BsiMax®, addresses direct whole blood ID/AST, and NicuMax® GN ID/AST is a sub-panel of BsiMax® GN ID/AST specifically to address low blood volume from neonates. All current systems and the proposed filed deployable device utilize the same assay protocols, reagents and electrochemical sensor array technologies.