T2 Biosystems Announces FDA 510(k) Clearance For Expanded T2Bacteria Panel

(RTTNews) - T2 Biosystems, Inc. (TTOO) on Monday said it received 510(k) clearance from the FDA for the expanded T2Bacteria Panel. Following this news the stock surged 26%.

This updated panel now has the added capability to detect another bacterial species, Acinetobacter baumannii (A. baumannii), which is a commonly found bacteria that causes bloodstream infections, especially in critically ill patients, and can be fatal if left untreated.

John Sperzel, Chairman and CEO of T2 Biosystems said, "The addition of A. baumannii … increases the value proposition of the T2Bacteria Panel by covering approximately 75% of all sepsis-causing bacterial pathogens commonly found in bloodstream infections."

The company stated that the T2Bacteria Panel is the first and only FDA-cleared product that can detect sepsis-causing pathogens directly in whole blood, in just 3 to 5 hours compared to the traditional method of growing bacteria in blood cultures, which can take days to provide a positive result.

TTOO is trading on the Nasdaq at $6.19, up 26.58% or $1.30 per share. It has traded between $3.36 and $142.00 in the past 52-week period.