Rapid diagnostics from whole blood for bacterial and fungal pathogens
T2 Biosystems’ T2Bacteria® and T2Candida® Panels are the first and only FDA-cleared and CE-marked tests that identify the most serious bacterial and fungal pathogens directly from blood sample in just three to five hours, without waiting for a positive blood culture —which can take one to six or more days. These capabilities allow for faster species identification, enabling the potential for faster targeted treatment, de-escalation of empiric therapy and improved patient outcomes.
All T2Direct DiagnosticsTM panels are run on the T2Dx® Instrument using a patient’s blood sample with validated clinical sensitivity of 91 to 96% and specificity of 98 to 99%. The direct from blood capability is enabled by the proprietary T2MR-powered T2Dx® Instrument which can detect organisms at concentrations as low as 1 CFU/mL. This represents a thousandfold increase in sensitivity compared to products that detect species from positive blood culture bottles where the number of cells is typically in the range of 10,000 to 10,000,000 CFUs/mL.
T2 Biosystems recently received FDA Breakthrough Designation for the T2ResistanceTM Panel, a diagnostic panel that can detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample in 3 to 5 hours. The T2Resistance Panel is also run on the T2Dx instrument and is expected to be CE-marked and available in Europe by the end of 2019, and offered as a Research Use Only product in the United States before yearend.
T2 Biosystems will showcase its latest innovations at ECCMID at Booth #1.22.