This product is available for research use only and is not cleared for diagnostic use.
The T2Cauris™ Panel RUO provides direct detection of the emerging superbug Candida auris in patient skin and patient blood and is now available for research use. The Centers for Disease Control and Prevention (CDC) validated the T2Cauris™ Panel RUO swab test on patient skin samples and published their findings in Mycoses.1
A serious global threat: Candida auris is a multidrug-resistant pathogen recognized by the CDC as a serious global health threat because it can be resistant to all three major classes of antifungal drugs and difficult to identify. The CDC has also reported that more than 1 in 3 patients with C. auris infections has died.2 Unlike most other species of Candida, C. auris can spread quickly in a hospital, making rapid identification and hospital environment surveillance a critical component of containing outbreaks. Reported cases of C. auris have surged internationally, and the CDC has reported a significant increase in infected patients in the United States. Because C. auris can be resistant to most treatment options, hospital outbreaks have been difficult to contain by even the most enhanced control measures.
Existing diagnostics suffer from extended detection times and low accuracy: Existing laboratory methods that detect C. auris, including blood culture, suffer from prolonged detection times and low accuracy, which exacerbates the challenge in the fight to contain the superbug. The CDC utilizes culture-based methods that require 14 days for results.
A new rapid diagnostic assay: The T2Cauris Panel demonstrated significant superiority in time advantages (<5 hours) compared to culture methods that took 14 days and inability to detect low levels of C. auris. The T2Candida auris Panel can detect levels as low as which is < 5 CFUs/mL which is greater than a 100-fold increase in sensitivity compared to other molecular diagnostic tests for C. auris.1,3,4,5 Additional data was presented by T2 Biosystems in a poster on the T2Candida auris assay at IDWeek 2017.6
T2 Biosystems has demonstrated the following performance in the detection of C. auris:
Contact us to request a demo of the T2Cauris Panel!
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1. Sexton DJ, et al. Mycoses, 2018
2. Centers for Disease Control and Prevention, 2017
3. Sexton DJ, et al. Journal of Clinical Microbiology, 2018
4. Kordalewska M, et al. Journal of Clinical Microbiology, 2017
5. Leach L, et al. Journal of Clinical Microbiology, 2018
6. Manning B, et al. Poster Presentation, IDWeek, 2017
>89% Sensitivity1,* | 98% Specificity1,*
— C. auris
— C. duobushaemulonii
— C. haemulonii
Method validated by CDC for patient swabs
Demonstrated performance in whole blood
Research Use Only (RUO)
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®, T2Resistance® 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™, T2Lyme™ and T2SARS-CoV-2™ are trademarks of T2 Biosystems, Inc.
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