Benzinga | Jan 11, 2022 09:05AM EST

T2 Biosystems Announces Initiation Of T2Resistance Panel Clinical Trial

T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens, today announced the initiation of a U.S. multi-site clinical trial evaluating the performance of its T2Resistance(r) Panel designed to support a submission to the U.S. Food and Drug Administration (FDA).



The T2Resistance(r) Panel, which runs on T2 Biosystems' T2Dx(r) Instrument, is a direct-from-blood test panel that detects 13 antibiotic resistance genes from both Gram-positive and Gram-negative bacterial pathogens, which are known to cause antibiotic-resistant infections that may lead to sepsis, and provides results in 3-5 hours without the need to wait for blood culture. The T2Resistance(r) 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.

The Company plans to file the FDA submission for the T2Resistance(r) Panel in 2022 following completion of the clinical trial, which will include up to 1,500 patients across 10 U.S. hospitals. The trial is estimated to cost T2 Biosystems $2,500,000.

"We are pleased to have initiated the U.S. clinical trial for the T2Resistance(r) Panel ahead of schedule, which should provide a path to file the FDA submission during 2022," said John Sperzel, Chairman and CEO at T2 Biosystems. "We believe the detection of antibiotic resistant genes directly from whole blood in 3-5 hours would be a game changer in the U.S., as data show that each hour of delayed targeted treatment increases mortality risk by up to 8%. The T2Resistance(r) Panel enables rapid detection of the common antibiotic resistance genetic markers and aids clinicians in targeting appropriate antimicrobial therapy for their patients when time is most critical. We intend to expand our sepsis product portfolio of culture independent diagnostic tests through the addition of the T2Resistance(r) Panel in the U.S. market, and we thank BARDA for its continued support to address the growing threat of antimicrobial resistance."

Antimicrobial resistance is considered one of the greatest threats to global health. The U.S. Centers for Disease Control and Prevention estimates at least 2.8 million people are infected with antimicrobial-resistant bacteria or fungi in the U.S. each year, and more than 35,000 die as a result. Prudent use of antimicrobials reduces the risk of developing antimicrobial resistance and leads to a positive public health impact. Current standard of care therapy, blood culturing and the use of broad spectrum antibiotics, contributes to the overuse of antimicrobials and drives increases in global drug resistance rates. A culture-independent diagnostic would save critical time, improve therapeutic decision making by clinicians and improve patient outcome.

This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. 75A50119C00053.