T2 Biosystems Announces New Publication Highlighting The Clinical Benefits And Performance Of The T2Resistance Panel

Author: Happy Mohamed | March 18, 2024 09:06am

T2 Biosystems, Inc. (NASDAQ:TTOO) (the "Company"), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced the publication of a new study highlighting the clinical benefits and performance of real-world use of the T2Resistance® Panel in The Journal of Clinical Microbiology. The European study demonstrated high accuracy for the T2Resistance Panel, faster detection times, and the impact of faster test results on clinical interventions based on T2 sepsis test results.
 

"This publication is the strongest demonstration to date of the clinical impact the T2Resistance Panel in a real-world hospital setting," said John Sperzel, Chairman and CEO of T2 Biosystems. "We believe the growing dataset will be a catalyst for increased adoption in countries that accept the CE Mark where the T2Resistance Panel is currently available. We also believe the international clinical experience with direct-from-blood detection of resistance genes is an important precursor to our launch in the U.S. market, where we have already received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA), and plan to submit a 510(k) premarket notification to the FDA later this year."

Highlights from the two-center prospective trial of 59 patients, intended to determine the clinical sensitivity, time to detection and the performance of T2Resistance as compared to blood culture and conventional microbiological methods, include:

• High Accuracy: The T2Resistance Panel demonstrated 94.7% clinical sensitivity and 97.4% specificity (adjudicated).
• Rapid Turnaround Time: The T2Resistance Panel results were available in 4.4 hours compared to 58.3 hours with blood culture-based methods.
• Clinical Impact: Across 59 patients in the study, there were 49 clinical interventions, resulting in 17 antibiotic escalations and 32 discontinuations of unnecessary antibiotics.
   

The publication, A prospective observational pilot study of the T2Resistance panel in the T2Dx system for detection of resistance genes in bacterial bloodstream infections Walsh et al., noted in summary, "T2R (T2Resistance) markers were highly sensitive for the detection of drug resistance genes in patients with bacterial BSIs (Blood Stream Infections), when compared with standard molecular resistance detection systems and phenotypic identification assays while significantly reducing by approximately 90% the time to detection of resistance compared to standard methodology and impacting clinical decisions for antimicrobial therapy."

About the T2Resistance Panel 

The T2Resistance Panel, which runs on T2 Biosystems' FDA-cleared T2Dx® Instrument, is a direct-from-blood test panel that detects 13 antibiotic resistance genes from both Gram-positive and Gram-negative bacterial pathogens (KPC, OXA-48, CTX-M-14/15, AmpC (CMY/DHA), NDM/IMP/VIM, mecA/C, vanA/B) in 3-5 hours without the need to wait for blood culture. The T2Resistance® Panel is commercially available in Europe under a CE mark and was granted "Breakthrough Device" designation from the FDA, which provides for a prioritized FDA review process.

Posted In: TTOO