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Release Date: April 26, 2023

T2Resistance 510 (k) Study

George Pankey, MD, Director of Infectious Disease Translational Research (pictured second from right) is the principal investigator at Ochsner for the T2Resistance 510 (k) study. In addition, he served on the T2Resistance Study Advisory Board.

Early identification and antimicrobial susceptibility testing of bloodstream pathogens is important for prompt appropriate therapy. The purpose of this study is to assess a new investigational diagnostic test (T2Resistance panel) to detect antibiotic resistance genes in patients’ blood samples.

The study device is a molecular diagnostic test and instrument that has been developed for the rapid detection of 13 different resistant genes found in bloodstream infections that can cause sepsis and bacteremia. Results from this rapid test can be available in 3-5 hrs vs. a blood culture with antibiotic susceptibility results in 3-5 days.

The research team consisted of (pictured left to right): Austin Jabbour, MD, Coordinator; Maria Latsis, Clinical Research Manager; Susan Scariano, Regulatory Coordinator; Debbie Ashcraft, Translational Research Lab Supervisor; Heather Davis, Research technician; Tia Mason, Coordinator; Samantha Smith, Research technician; Malika Morar, MD, Coordinator; and Royanne Vortisch, Lab assistant.

This study included 10 investigational sites with a total target enrollment of 1500 subjects from all sites. Ochsner was the top enrolling site with 354 patients and the first site to begin enrollment and reach our target prior to most other sites opening enrollment. Our team helped streamline processes used here at Ochsner which, in turn, were utilized by the sponsor for the other study sites. The study was funded by T2 Biosystems, and data from this study will be submitted to the FDA for clearance of the device.