AdvanDx has launched Gram-NegativeQuickFISH BC, its new rapid molecular diagnostic test that identifies potentially life threatening bloodstream infections caused by Escherichia coli, and/orPseudomonas aeruginosaand/orKlebsiella pneumonia.
The new test, which is the third FDA-cleared test in AdvanDx’s QuickFISH pathogen identification platform, provides rapid identification directly from GNR-positive blood cultures in just 20 minutes.
It is also the first molecular test fast enough to report pathogen identification with Gram stain results available in the market.
Gram-Negative QuickFISH BC can aid the clinicians in improving mortality rates and patient survival by timely suggesting the use of appropriate therapy for gram-negative pathogens.
AdvanDx chief technology officer Dr Jim Coull said the unmatched speed and simplicity of the QuickFISH procedure, which allows the laboratory to report pathogen identification to clinicians with the Critical Value Gram stain result, provides an unprecedented ability to optimize therapy within half an hour of receiving a positive blood culture.
"Before QuickFISH, clinicians did not have the ability to know which species of pathogen was responsible for a positive blood culture at the time they received the initial Gram Stain results, but now QuickFISH can provide rapid pathogen identification that enables them to better optimize antibiotic therapy.
"QuickFISH is also specifically designed to address laboratory workflow needs by providing microbiology technologists an easy to use 20 minute test with less than five minutes of hands on time," Dr Coull added.
The new gram-negative assay is immediately available and further expands AdvanDx’s QuickFISH platform that can now identify the pathogens responsible for 90% of positive blood cultures.
AdvanDx expects commercial launch of its fourthQuickFISH assay for the identification of Candida species from positive blood cultures in the second half of 2013, following regulatory clearance.