T2 Biosystems receives CE Mark for T2Bacteria Panel
T2 Biosystems announced that it has received a CE Mark for its T2Bacteria Panel, allowing for the sale and distribution of the product within the European Union and those countries accepting the CE Mark. The T2Bacteria Panel runs on the company's proprietary T2Dx Instrument and provides highly accurate species-specific test results of targeted bacterial infections direct from whole blood in as fast as about 3.5 hours, and without the need for a time-consuming blood culture. The T2Bacteria Panel is currently available in the United States for Research Use Only, or RUO, and the company is in the final stages of completing the FDA pivotal trial, after which a 510(k) application will be submitted to the FDA. Patient enrollment in the trial is currently 92% complete and the company is very pleased with the product performance demonstrated to date, which for the prospective arm of the study is showing an average sensitivity of 96% and average specificity of 98%.