T2 Bacterial Panel Obtain FDA Approval; Provides Rapid Diagnosis of Sepsis

There is exciting news in the area of clinical bacteriology. The FDA has approved the T2 Biosystems bacterial panel for the rapid detection of septicemia (see: T2 Biosystems Receives FDA Clearance to Market T2Bacteria Panel for Detection of Sepsis-Causing Pathogens), Below is an excerpt from the article:T2 Biosystems...announced that it has received market clearance from the U.S. Food and Drug Administration (FDA) for the T2 Bacteria Panel for the direct detection of bacterial species in human whole blood specimens from patients with suspected bloodstream infections. The T2Bacteria Panel... provides sensitive detection of specific sepsis-causing bacterial pathogens directly from a whole blood specimen in approximately 5 hours. This was more than 2.5 days faster than blood culture-dependent tests as demonstrated in the over 1,400 patient pivotal trial conducted at 11 hospitals in the United States. All other FDA-cleared diagnostic tests that detect bacteria in blood require a positive blood culture sample prior to bacterial species specific identification, which typically delays results by one to five days.For patients at risk of sepsis, rapid targeted treatment based on the identification of causative pathogens is critical because it is estimated that every hour of speeding up the time to targeted therapy decreases patient mortality by nearly 8%....The T2 Bacteria Panel, like the previously FDA-clearedT2 Candida Panel, runs on the Company ’s proprietary, FDA-cle...
Source: Lab Soft News - Category: Laboratory Medicine Authors: Tags: Clinical Lab Industry News Clinical Lab Testing Cost of Healthcare Food and Drug Administration Lab Industry Trends Medical Research Quality of Care Source Type: blogs