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-cleared T2 Candida Panel, runs on the Company’s proprietary, FDA-cleared T2Dx Instrument....Studies have shown that the mortality rate for bloodstream infections can be reduced significantly with appropriate targeted therapy within 12 hours....Treating bloodstream infections earlier may prevent progression to sepsis, one of the leading causes of death in the U.S. and the most expensive hospital-treated condition, with costs exceeding $27 billion. Sepsis claims more lives annually than breast cancer, prostate cancer, and AIDS combined and is the most prevalent and costly cause of hospital readmissions. The pathogens that cause sepsis infections are difficult to detect and can be deadly even at very small concentrations in the bloodstream.

Copied from the T2 web site, here's an explanation of the underlying technology used by the company for rapid detection and speciation of bacteria in whole blood:

To detect diagnostic targets, T2MR utilizes advances in the field of nanotechnology. Specifically, T2MR technology (T2MR applications):

• Deploys particles with superparamagnetic properties that enhance the magnetic resonance signals of specific binding events. 
• When particles coated with target-specific binding agents are added to a sample containing the target, the particles bind to and cluster around the target. 
• This clustering changes the microscopic environment of water molecules in that sample, which, in turn, alters the magnetic resonance signal, or the T2 relaxation signal measured, indicating the presence, absence or concentration of the target.

There is no need to belabor this point. Rapid diagnosis of septicemia with identification of the infectious agent will undoubtedly save money and lives. Sounds to me like a major advance in lab medicine.