T2 Biosystems announces new publication on T2Resistance Panel

T2 Biosystems 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, and plan to submit a 510(k) premarket notification to the FDA later this year.”