T2 Biosystems (TTOO) Granted FDA 510(k) Clearance for the Expanded T2Bacteria Panel
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T2 Biosystems, Inc. (NASDAQ: TTOO) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded T2Bacteria® Panel, adding the capability to detect another bacterial species, Acinetobacter baumannii (A. baumannii), to the expansive panel.
A. baumannii is a cause of bloodstream infections, especially in critically ill patients, which can range from benign transient bacteremia to septic shock. In a large study of nosocomial bloodstream infections, A. baumannii was the tenth most common pathogen and has a crude ICU mortality rate of 34.0% to 43.4%. A. baumannii infections typically occur in people in healthcare settings and pose risk to those who are on ventilators, have devices such as catheters, have open wounds from surgery, are in intensive care units, or have prolonged hospital stays.
“We are thrilled to receive the FDA 510(k) clearance for the expanded T2Bacteria Panel, to include the detection of A. baumannii, as we believe it will lead to increased adoption of our proprietary direct-from-blood platform,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “The addition of A. baumannii represents the achievement of another successful product development and regulatory milestone for T2 Biosystems and increases the value proposition of the T2Bacteria Panel by covering approximately 75% of all sepsis-causing bacterial pathogens commonly found in blood stream infections.”
Due to the emergence of pan-antibiotic resistant A. baumannii, the World Health Organization has identified A. baumannii as the most critically important bacteria that requires improved prevention and therapeutic approaches. There are few antimicrobial options for carbapenem resistant A. baumannii, which can increase mortality rates to 70%. Acinetobacter resistance to many antibiotics, including carbapenems, highlights the importance of rapid detection and targeted antimicrobial treatment.
The T2Bacteria Panel is the first and only FDA-cleared product able to detect sepsis-causing pathogens directly in whole blood, in 3 to 5 hours, without the need to wait days for a positive blood culture. The FDA-cleared T2Bacteria Panel now detects E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, E. coli, and A. baumannii. Rapid detection of these pathogens is essential to getting infected patients on the appropriate antimicrobial therapy and improving clinical outcomes.
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