T2 Biosystems has multiple diagnostic applications in development, all designed to enable further breakthroughs in rapid and accurate therapy for patients. The diagnostics are focused on critical, unmet needs in healthcare, where solutions can serve a dual role of improving patient care while reducing costs.
T2 Biosystems has partnered with CARB-X and BARDA to develop the T2Resistance Panel. The T2Resistance Panel detects gram-negative and gram-positive resistance markers and has received FDA Breakthrough Device Designation. The company plans to submit a 510(k) premarket notification in 2024.
The CE-marked panel is available in Europe and other countries and clinical findings have been published in The Journal of Clinical Microbiology.
Candida auris: The addition of Candida auris to the T2Candida Panel is currently in the product development phase. Upon its completion, we will seek FDA 510(k) clearance to include the detection of Candida auris on the T2Candida Panel, which is already FDA-cleared, and CE-marked. The T2Cauris Panel received FDA Breakthrough Device designation in July 2023.
The CDC* validated the T2Cauris Panel RUO swab test on patient swab samples and published their 2017 findings in Mycoses.1
T2Candida for pediatrics: T2 Biosystems has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) to expand the use of its FDA-cleared T2Candida® Panel to include pediatric testing.
In early 2024, we received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded T2Bacteria® Panel, adding the capability to detect another bacterial species, Acinetobacter baumannii, to the expansive panel.
T2 Biosystems plans to commercialize the T2Lyme Panel as a laboratory developed test (LDT) and is currently in discussions with potential LDT partners and plans to provide early Lyme disease results to U.S. reference laboratories nationwide.
Our pipeline encompasses a diverse range of innovative solutions.
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1. Sexton DJ, et al. Mycoses, 2018*The 2017 CDC findings identified the T2Cauris Panel RUO as a rapid diagnostic that demonstrated significant time advantages (<5 hours) compared to culture methods that take 14 days. Additional data from a collaboration with a European hospital was presented by T2 Biosystems in a poster on the T2Cauris Panel at IDWeek 2017.
Learn more about how you can develop additional breakthrough applications utilizing our T2MR platform.
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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