FDA Clearance for T2 Biosystems Diagnostic Panel
T2 Biosystems, Inc. (Nasdaq: TTOO) has received 510(k) clearance from the FDA for its expanded T2Bacteria® Panel, adding the capability to detect another bacterial species, Acinetobacter baumannii (A. baumannii), to its panel.
The T2Bacteria Panel is the first and only FDA-cleared product able to detect sepsis-causing pathogens directly in whole blood, in just 3 to 5 hours. It detects E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, E. coli, and A. baumannii.
John Sperzel, Chairman and CEO of T2 Biosystems, commented on the news: “We are thrilled to receive the FDA 510(k) clearance for the expanded T2Bacteria Panel, to include the detection of A. baumannii, as we believe it will lead to increased adoption of our proprietary direct-from-blood platform. The addition of A. baumannii represents the achievement of another successful product development and regulatory milestone for T2 Biosystems and increases the value proposition of the T2Bacteria Panel by covering approximately 75% of all sepsis-causing bacterial pathogens commonly found in bloodstream infections.”
Highlights
A. baumannii is a cause of bloodstream infections, especially in critically ill patients, and can result in septic shock.
Infections pose a significant risk to patients on ventilators, those with catheters or open wounds from surgery.
The World Health Organization has identified A. baumannii as the most critically important bacteria that requires improved prevention and therapeutic approaches.
About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2Biothreat™ Panel, and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the Candida auristest, and the T2Lyme™ Panel. For more information, please visit www.t2biosystems.com.
