Through the Food and Drug Administration’s de novo premarket review pathway, Accelerate Diagnostics has received authorization to market the Pheno Test BC kit. After a positive blood culture, this test identifies in approximately 1.5 hours 14 different species of bacteria and two species of yeast that cause bloodstream infections. For a subset of these organisms, it then provides in approximately 6.5 hours information on sensitivity to 18 selected antibiotics. Additionally, the Pheno Test BC kit detects the presence of two indicators of antibiotic resistance. Performed on the Pheno system, the test works by measuring the similarity of the infection-causing organism’s genetic material to DNA known to be unique to specific bacteria or yeast. Once the organism is identified, it is mixed with antibiotics and the growth of the bacteria is measured by time-lapse images. If the organism does not grow when a particular antibiotic is present, this indicates that the antibiotic may be used for treatment.