FDA clears T2 Biosystems’ panel to detect sepsis bacteria

31 May 2018 (Last Updated June 1st, 2018 12:29)

Diagnostic products developer T2 Biosystems has obtained marketing clearance from the US Food and Drug Administration (FDA) for its new panel to directly identify the sepsis-causing bacteria species.

FDA clears T2 Biosystems’ panel to detect sepsis bacteria
The T2Bacteria Panel is placed into the T2Dx Instrument to identify sepsis-causing bacteria directly from whole blood. Credit: T2 Biosystems.

Diagnostic products developer T2 Biosystems has obtained marketing clearance from the US Food and Drug Administration (FDA) for its new panel to directly identify the sepsis-causing bacteria species.

The T2Bacteria Panel can analyse whole blood specimens from patients who are suspected to have bloodstream infections. It is said to deliver results in around five hours.

It is run on the T2Dx Instrument, and can identify species of Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Staphylococcus aureus.

“When investigated in a pivotal trial at 11 US hospitals in a total of more than 1,400 patients, the panel was observed to be 2.5 days faster when compared to blood culture-dependent tests.”

T2 Biosystems president and CEO John McDonough said: “The FDA’s market clearance of the T2Bacteria Panel is a significant milestone for our company, but more importantly, for millions of patients at risk of sepsis from bloodstream infections.

“This breakthrough technology provides potentially life-saving answers for patients and economic savings to hospitals that bear the enormous burden of sepsis-related care and mortality.”

When investigated in a pivotal trial at 11 US hospitals in a total of more than 1,400 patients, the panel was observed to be 2.5 days faster when compared to blood culture-dependent tests.

This is considered beneficial as sepsis patients require rapid targeted treatment depending on the identification of causative pathogens, because every one hour delay is known to reduce patient mortality by almost 8%.

In addition, the panel is reported to have demonstrated 90% overall average sensitivity and 98% of overall average specificity, without any interference from bacterial presence in the bloodstream.

Statistics show sepsis affects 1.6 million people in the US annually, leading to more than 250,000 deaths and around half of all deaths of hospitalised patients.