T2 Biosystems Inc, Lexington, Mass, has received FDA premarket notification (510(k)) clearance for the company’s T2Bacteria panel for the direct detection of bacterial species in human whole blood specimens from patients with suspected bloodstream infections.
The T2Bacteria panel detects specific sepsis-causing pathogens in approximately 5 hours, more than 2.5 days faster than blood culture-dependent tests, according to a pivotal clinical trial. For patients at risk of sepsis, rapid targeted treatment based on the identification of causative pathogens is critical, since each hour saved reduces patient mortality by nearly 8%.
“The T2Bacteria panel’s rapid results and high sensitivity make it a valuable tool for the diagnosis and management of suspected bloodstream infections,” says W. Frank Peacock IV, MD, FACEP, FACC, professor and associate chair of emergency medicine at 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 10-fold improvement in time-to-result demonstrated in the pivotal clinical trial, the T2Bacteria panel also achieved an overall average sensitivity of 90% and an overall average specificity of 98%, while exhibiting 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,” says Minh-Hong Nguyen, MD, director of antimicrobial management and transplant infectious diseases at the University of Pittsburgh Medical Center. “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.”
John McDonough, T2 Biosystems.
The T2Bacteria panel runs on the company’s proprietary, FDA-cleared T2Dx instrument and 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 US patients each year and causes nearly half of all patient deaths in US hospitals. Appropriate targeted therapy initiated within 12 hours reduces the mortality rate for bloodstream infections.
“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,” says John McDonough, president and CEO 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.”
For further information, visit T2 Biosystems.
Featured image: The T2Bacteria panel is placed into the T2Dx instrument to identify sepsis-causing bacteria directly from whole blood. Photo courtesy T2 Biosystems.
