T2 Biosystems, Inc., a provider of solutions for the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) to expand the number of pathogens detected on the FDA-cleared T2Bacteria Panel to include the detection of Acinetobacter baumannii (A. baumannii).

A. baumannii is a cause of bloodstream infections especially in critically ill patients, which can range from a 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 excited about the potential to expand the number of pathogens detected by our FDA-cleared T2Bacteria Panel to include the detection of A. baumannii,” says John Sperzel, chairman and CEO of T2 Biosystems. “We believe the addition of A. baumannii will lead to increased adoption as it increases the detection capabilities of our FDA-cleared T2Bacteria Panel to 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 currently detects E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, and E. coli, and the CE marked version detects the aforementioned pathogens plus A. baumannii. Rapid detection of these pathogens is essential to getting infected patients on the appropriate antimicrobial therapy and improving clinical outcomes.