FDA OKs T2 Biosystems’ Rapid Sepsis Test

T2 Biosystems, Inc., an emerging company involved in the development and commercialization of diagnostic products for critical unmet needs in healthcare, today announced that it has received market clearance from the U.S. Food and Drug Administration (FDA) for the T2Bacteria Panel for the direct detection of bacterial species in human whole blood specimens from patients with suspected bloodstream infections. The T2Bacteria Panel, for the first time, 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 percent.
 
“The T2Bacteria Panel’s rapid results and high sensitivity make it a valuable tool for the diagnosis and management of suspected bloodstream infections,” said W. Frank Peacock, M.D., FACEP, FACC, professor, associate chair, Baylor College of Medicine. “This is an important breakthrough as bacterial infections are a major cause of poor patient outcomes and high hospital costs. This is a game-changer.”
 
In addition to the more than tenfold improvement in time to result demonstrated in the pivotal clinical trial, the T2Bacteria Panel also achieved an overall average sensitivity of 90 percent and an overall average specificity of 98 percent, while demonstrating no interference from the presence of antibiotics in the bloodstream.
 
“The results from the T2Bacteria pivotal clinical trial were impressive, demonstrating excellent performance and advantages over blood culture,” said Minh-Hong Nguyen, M.D., director, Antimicrobial Management Program and director, Transplant Infectious Diseases, UPMC. “T2Bacteria’s detection of bloodstream infections and fast species identification at high sensitivity will expedite life-saving interventions such as the targeting of therapy within hours of blood draw.”
 
The T2Bacteria Panel, like the previously FDA-cleared T2Candida Panel, runs on the Company’s proprietary, FDA-cleared T2Dx Instrument. The FDA-cleared T2Bacteria Panel identifies five of the most common and deadly sepsis-causing species of bacteria: Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus.
 
Bacterial and fungal bloodstream infections are a leading cause of sepsis, a life-threatening illness that affects 1.6 million U.S. patients each year, resulting in over 250,000 deaths or almost 50 percent of all deaths of U.S. hospitalized patients. Studies have shown that the mortality rate for bloodstream infections can be reduced significantly with appropriate targeted therapy within 12 hours.
 
“The FDA’s market clearance of the T2Bacteria Panel is a significant milestone for our company, but more importantly, for millions of patients at risk of sepsis from bloodstream infections,” said John McDonough, president and chief executive officer of T2 Biosystems. “This breakthrough technology provides potentially life-saving answers for patients and economic savings to hospitals that bear the enormous burden of sepsis-related care and mortality.”