T2 Biosystems Inc. (NSDQ:TTOO) said today it won CE Mark approval in the European Union for its T2Bacteria Panel magnetic resonance-based bacterial detector, and said that it has entered the final stages of its FDA pivotal trial as it seeks 510(k) approval from the agency.
The T2Bacteria Panel is designed to run on the company’s T2Dx instrument, a miniaturized MR diagnostic device, to provide species-specific test results of targeted bacterial infections in approximately 3.5 hours, the Lexington, Mass.-based company said.
The T2Bacteria Panel is designed to identify 6 of the deadliest prevalent bacteria species not covered by empiric therapy. The company said the system can identify approximately 90% of gram-negative infections coming in through ER departments and 70% of community-acquired infections in emergency departments.
The device is slated for a commercial launch as part of its T2Sepsis Solution in Europe during the 3rd quarter of this year, T2 Biosystems said.
“The CE Mark of our T2Bacteria Panel is a significant milestone in our mission to save lives and improve healthcare by empowering clinicians to more effectively treat patients with sepsis faster than ever before. Our T2Sepsis Solution now includes T2Candida and T2Bacteria, creating a significant opportunity to expand our target hospitals and positioning T2 Biosystems for accelerated commercial growth,” prez & CEO John McDonough said in a press release.
The company said that patient enrollment in its pivotal FDA trial of the T2Bacteria Panel is at 92%, and that initial results from the trial show an average sensitivity of 96% and average specificity of 98%.
“We are pleased to be close to finalizing the submission of our T2Bacteria Panel to the FDA. Even more encouraging are the early responses we have been receiving from hospitals taking advantage of the T2Bacteria Panel under the RUO program. We believe the RUO program will provide independent data for hospitals to present at conferences and for publications later this year and into 2018,” chief scientific officer Tom Lowery said in a prepared statement.
Last month, T2 Biosystems touted data showing that its miniaturized magnetic resonance diagnostic tech can detect Lyme disease-causing bacteria in clinical blood samples. The preclinical study was published in the Journal of Clinical Microbiology.
