Addressing the unmet need for faster detection of antimicrobial resistance
The first direct-from-blood detection of resistance markers:
The T2Resistance® Panel* is the only culture-independent diagnostic assay for the detection of antibiotic resistance genes associated with sepsis-causing pathogens. Utilizing the same T2Dx® Instrument as the T2Bacteria® Panel and T2Candida® Panel, the T2Resistance Panel identiﬁes 13 of the most serious resistance genes on the antibiotic-resistance threat list published by the Centers for Disease Control and Prevention (CDC), including genes indicating resistance to common empiric antibiotic therapies such as carbapenems, vancomycin, penicillin and more.
The panel has a clinical sensitivity and specificity of ≥99% and a limit of detection (LoD) as low as 3-11 CFU/mL.1 The panel is currently available as a CE/IVD-marked product and was granted “Breakthrough Device” designation by the FDA in 2019 for providing a more effective diagnosis of life-threatening or irreversibly debilitating human disease, reflecting the purpose of the panel to rapidly identify resistant infections.
Early Clinical Data2:
A study was conducted in which 57 patients were enrolled based on the criteria of having symptoms consistent with those of a bloodstream infection. The data showed that the T2Resistance Panel is sensitive and specific for the detection of drug resistance genes while significantly reducing time to detection. One location that participated in the study demonstrated an average time to result of just 3.6 hours with T2Resistance, which was 97.8 hours faster than the standard blood culture and antibiotic susceptibility testing (AST) method.
T2MR® Technology: The T2Resistance Panel utilizes the same T2Dx Instrument® as the T2Bacteria® and T2Candida® Panels – the first and only FDA-cleared and CE-marked panels for detection of sepsis-causing bloodstream infections direct from a patient’s blood sample, without requiring blood culture results.
Contact us to learn more about the T2Resistance Panel!
Patient Case Study – Gemelli Hospital | Rome, Italy2
Early clinical data demonstrate the identification of a positive KPC K. pneumoniae infection by the T2Resistance and T2Bacteria Panels, which helped to optimize therapy in just ~7 hours from specimen collection.
Walsh, TJ., et al. Prospective Study of the T2Resistance (T2R) System for Detection of Resistance Genes in Bacterial Bloodstream Infections. Abstracts of the European Congress for Clinical Microbiology and Infectious Diseases (ECCMID), Abstr 3434; 2021. 2019.
Gram-negative marker KPC OXA-48 Group NDM /VIM/IMP CTX-M 14/15 AmpC(CMY/DHA)
Gram-positive marker vanA/B mecA/C
T2 BIOSYSTEMS OVERVIEW
T2 Biosystems, an emerging leader in the field of in vitro diagnostics, is dedicated to saving lives and reducing the cost of healthcare by empowering clinicians to effectively treat patients faster than ever before. T2 Biosystems is focused on addressing critical unmet needs in healthcare starting with sepsis, one of the deadliest and most expensive conditions in hospitals today.
The T2Dx Instrument, the T2Bacteria and T2Candida Panels have received marketing authorization from the U.S. Food and Drug Administration. All other T2 Biosystems products are considered investigational and for research use only.
T2 Biosystems®, T2MR®, T2Bacteria®, T2Candida®, and T2Dx® are registered trademarks of T2 Biosystems, Inc. “T2Biosystems” and the T2 Biosystems, Inc. logo design are registered trademarks or trademarks of T2Biosystems, Inc. All software and documentation is subject to T2 Biosystems, Inc. copyrights. All rights reserved. T2Direct Diagnostics™, T2HemoStat™, T2Plex™, T2Cauris™, T2Resistance™ and T2SARS-CoV-2™ are trademarks of T2 Biosystems, Inc.
Check out our latest #whitepaper containing clinical trial data, real-world evidence, and example algorithms that detail how T2Candida can be incorporated into practice and improve care for invasive candidiasis in your own practice.