On March 18, 2024, T2 Biosystems, Inc., a medical device company based in Lexington, Massachusetts, announced the publication of a study in The Journal of Clinical Microbiology, which showcased the clinical benefits and performance of the T2Resistance Panel. The study, conducted in Europe, involved a two-center prospective trial with 59 patients and aimed to compare the T2Resistance Panel's clinical sensitivity, time to detection, and performance against blood culture and conventional microbiological methods. The T2Resistance Panel demonstrated a high clinical sensitivity of 94.7% and specificity of 97.4%. Notably, the panel's results were available in 4.4 hours, significantly faster than the 58.3 hours typically required for blood culture-based methods. The study reported 49 clinical interventions, including 17 antibiotic escalations and 32 discontinuations of unnecessary antibiotics, highlighting the panel's impact on clinical...Show More

On March 18, 2024, T2 Biosystems, Inc., a medical device company based in Lexington, Massachusetts, announced the publication of a study in The Journal of Clinical Microbiology, which showcased the clinical benefits and performance of the T2Resistance Panel. The study, conducted in Europe, involved a two-center prospective trial with 59 patients and aimed to compare the T2Resistance Panel's clinical sensitivity, time to detection, and performance against blood culture and conventional microbiological methods. The T2Resistance Panel demonstrated a high clinical sensitivity of 94.7% and specificity of 97.4%. Notably, the panel's results were available in 4.4 hours, significantly faster than the 58.3 hours typically required for blood culture-based methods. The study reported 49 clinical interventions, including 17 antibiotic escalations and 32 discontinuations of unnecessary antibiotics, highlighting the panel's impact on clinical decision-making. T2 Biosystems also mentioned plans to submit a 510(k) premarket notification to the FDA later in the year, following the panel's Breakthrough Device designation. The company's press release included forward-looking statements about the potential for increased adoption of the T2Resistance Panel in CE Mark-accepting countries and its anticipated launch in the U.S. market.