T2 Biosystems submits notice to FDA to expand T2Bacteria Panel

T2 Biosystems, announced that it 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 T2 Bacteria Panel to include the detection of Acinetobacter baumannii or 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..”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,” stated 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.”