Abstract

T2MR: Focused on Rapid & Sensitive Detection of Sepsis Pathogens Directly from Whole Blood Without Blood Culture

Frederic Sweeney, Senior Director, T2 Biosystems

Rapid diagnostic testing to narrow clinical trial populations and improve therapeutic efficacy has had limited benefit for antimicrobial therapies due to the low titer levels of infection and long diagnostic times required by the standard of care, blood culture. In order to truly make an impact in drug development as companion diagnostics, new technologies are required to deliver dramatically faster and more accurate results. The ideal diagnostics assays (1) would achieve clinically relevant limits of detection directly from patient samples, (2) would not rely on culture or enrichment and (3) would have very high positive and negative predictive values. T2 Magnetic Resonance (T2MR®) technology has the potential to deliver a rapid, sensitive and simple diagnostic platform that can identify specific pathogens directly from an unpurified blood sample as fast as three hours. T2MR does not require blood culture and can detect cellular targets at limits of detection as low as 1 CFU/mL. T2MR is being used to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. The first applications of T2MR are designed for the detection of sepsis-causing pathogens directly from an unpurified blood sample in hours at a level of accuracy equal to or better than blood culture-based diagnostics, which typically require 2 to 5 days to generate results. We believe that T2MR is the only technology that can reliably detect pathogens associated with sepsis, including slow-growing pathogens, directly from a patient’s blood sample, even in the presence of antimicrobial therapy. T2Dx®, our bench-top instrument currently available for investigational use only, utilizes T2MR and is designed to be fully automated from patient sample input to result.