NEW YORK (360Dx) – T2 Biosystems announced today that its has filed a 510(k) premarket submission for its T2Bacteria Panel with the US Food and Drug Administration.
The panel runs on the FDA-cleared T2Dx instrument and is designed to be a comprehensive rapid diagnostic test that identifies pathogens associated with sepsis within hours instead of days, T2 Biosystems said.
The T2Bacteria Panel is able to identify six species of bacteria directly from human whole blood specimens: Acinetobacter baumannii, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus.
The panel is commercially available in Europe and other countries that accept the CE mark, and is currently available for research use only in the US.
The FDA submission contains data from a clinical trial that evaluated T2Bacteria Panel's performance, compared to that of blood culture, as well as the panel's performance in known bacteria-positive samples. The combined results of the study demonstrate an average sensitivity of 96 percent and an average specificity of 98 percent.
"We have already seen significant interest from hospitals in using the product under a research-use only program that we offered on a limited basis this past spring," T2 Biosystems President and CEO John McDonough said in a statement.
Last week, T2 Biosystems announced a partnership with Cidara Therapeutics to target sepsis-causing bacteria.