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PRESS RELEASE: T2 Biosystems Gets FDA Clearance to Expand Bacteria Panel


T2 Biosystems announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to add Acinetobacter baumannii (A. baumannii) to its T2Bacteria Panel.

In its announcement, the company cited A. baumannii's designation by the World Health Organization (WHO) as a pan-antibiotic-resistant bacteria. A. baumannii causes bloodstream infections, especially in critically ill patients. These infections typically occur in healthcare settings and pose risk to those who are on ventilators, have devices such as catheters, have open wounds from surgery, are in intensive care units, or have prolonged hospital stays.

There are few antimicrobial options for carbapenem-resistant A. baumannii, which can increase mortality rates to 70%. Acinetobacter resistance to many antibiotics, including carbapenems, highlights the importance of rapid detection and targeted antimicrobial treatment, according to the company.

Designed to detect sepsis-causing pathogens directly in whole blood in under five hours, eliminating the wait for a positive blood culture, the FDA-cleared T2Bacteria Panel can also detect E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, and E. coli. It covers approximately 75% of all sepsis-causing bacterial pathogens commonly found in bloodstream infections, the company said.

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