By Chris Wack
T2 Biosystems has received 510(k) clearance from the U.S. Food and Drug Administration for the expanded T2Bacteria Panel, adding the capability to detect another bacterial species, Acinetobacter baumannii, to the expansive panel.
The company said A. baumannii is a cause of bloodstream infections, especially in critically ill patients, which can range from benign transient bacteremia to septic shock.
T2 said the addition of A. baumannii represents hitting another regulatory milestone and increases the value proposition of the T2Bacteria Panel by covering 75% of all sepsis-causing bacterial pathogens commonly found in blood stream infections.
The company said the T2Bacteria Panel is the first and only FDA-cleared product able to detect sepsis-causing pathogens directly in whole blood, in three to five hours, without the need to wait days for a positive blood culture.
Write to Chris Wack at firstname.lastname@example.org
(END) Dow Jones Newswires