Robust Clinical Data and Positive Customer Experience with T2Bacteria and T2Candida Panels Highlighted at Recent Medical Meetings
Presentations at ECCMID and MAD-ID meetings demonstrate clinically actionable results and cost savings achieved with these panels
Real-world experience reinforces multi-day time advantage demonstrated in the T2Bacteria 1,427-patient pivotal study, as compared to post-blood culture species identification tests
LEXINGTON, Mass., May 23, 2019 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative medical diagnostic products for critical unmet needs in healthcare, highlighted the latest clinical data and customer case studies for the T2Bacteria® and T2Candida® Panels that were presented at recent medical meetings.
In April, case studies of patients tested with the T2Bacteria Panel and T2Resistance™ Panel were presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Amsterdam in an Integrated Symposium by Dr. Giulia De Angelis from the Institute of Microbiology, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Agostino Gemelli in Rome, Italy. Key highlights from the case studies:
-- Three T2Bacteria clinical cases were reviewed showing an approximately 24 hour to 37 hour time savings over direct-from-blood-culture MALDI Biotyper and one T2Bacteria clinical case of culture-negative sepsis missed altogether by blood culture but detected by the T2Bacteria Panel. -- Multiple T2Carba Resistance+ clinical cases were reviewed showing an average of a 30 hour time savings (ranging from approximately 2 to 90 hours) with T2Carba Resistance+ over direct-from-blood-culture PCR methods. -- For T2Bacteria panel, Dr. De Angelis concluded: - “Study and clinical cases demonstrate the ability of the T2Bacteria Panel to detect infections and poly-microbial infections faster than blood culture.” - “Clinical case study demonstrates the ability for T2Bacteria to detect probable infections missed by blood culture.”
-- For the T2Resistance Panel, Dr. De Angelis concluded: - “Case studies demonstrate the opportunity for direct-from-blood resistance gene detection to provide results faster than blood culture-based diagnostics and to impact clinical care.”
In addition to Dr. De Angelis’ presentation during the Integrated Symposium, which was viewed by approximately 400 attendees, Professor Michael Bauer, MD, of Jena University; Dr. Cornelius (Neil) Clancy, of The University of Pittsburgh Medical Center; and Dr. Thomas Walsh, of New York Presbyterian Hospital gave presentations covering additional patient case studies and providing an overview of the application and clinical results using the T2Bacteria and T2Candida Panels for a variety of patients. Key highlights from these presentations:
-- Professor Bauer noted that “appropriate and rapid delivery of targeted antimicrobials is critical for surviving sepsis” and that rapid diagnostic tests can provide “cost savings with antimicrobial use as well as a reduction of length of stay associated costs.” -- Dr. Clancy provided patient case studies and noted that the T2Bacteria Panel is appropriate for a variety of patients, including those in the high-risk intensive care unit and the emergency department. -- Dr. Walsh concluded that the T2Bacteria and T2Candida Panels could improve outcomes for immunocompromised patients by providing earlier diagnosis and more sensitive detection of blood stream pathogens, thereby reducing length of stay and improving the chance of survival.
In addition, several poster presentations covering the T2Bacteria, T2Candida, and T2Resistance Panels were presented at ECCMID and the T2 Biosystems team met with potential customers at the Company’s booth and provided demonstrations on the ease-of-use of the T2Dx Instrument.
In May, new data supporting the use of the T2Bacteria and T2Candida Panels to improve antimicrobial stewardship programs was presented at the 22nd Annual MAD-ID (Making a Difference in Infectious Diseases) Meeting, The Antimicrobial Stewardship Meeting in Orlando, Florida. The Company hosted a satellite symposium that was viewed by approximately 200 attendees, and presented two scientific poster presentations. Key highlights from the symposium and posters:
-- Dr. Deanne Tabb of Piedmont Columbus Regional Midtown in Columbus, Georgia shared that use of the T2Bacteria Panel resulted in improved time to appropriate antibiotics and vancomycin trough goals, timely infectious diseases consultations for Staphylococcus aureus bacteremia and timely initiation of contact precautions. It also detected a case of blood culture negative K. pneumoniae pneumonia infection. -- Dr. Ryan Shields of The University of Pittsburgh Medical Center shared the successful results of T2Candida utilization as an antimicrobial stewardship tool, highlighting a 47% reduction in antifungal utilization.
All of the presentation slides and poster presentations from the ECCMID and MAD-ID meetings are available on the Publications and Presentations page of the T2 Biosystem’s website.
“The body of clinical evidence supporting the T2Bacteria and T2Candida Panels continues to grow, with impressive updates at the ECCMID and MAD-ID meetings,” said Tom Lowery, chief scientific officer of T2 Biosystems. “There are now more than two dozen published abstracts, clinical cases, and peer-reviewed studies covering our panels and we reached an important milestone with the publication of the T2Bacterial pivotal clinical trial results in the Annals of Internal Medicine, which is a high-impact peer-reviewed publication. It is encouraging that data continues to reinforce the key differentiating factors that are driving adoption of our test panels – a multi-day time advantage versus blood-culture dependent tests, with high sensitivity and specificity, which translates to better clinical outcomes, improved antimicrobial stewardship, and cost savings.”
The T2Bacteria and T2Candida Panels are the first and only FDA-cleared bacterial and fungal pathogen detection panels that are performed directly from a blood draw, without the wait for blood culture. They are able to identify sepsis-causing pathogens within 3 to 5 hours directly from whole blood, instead of days required with blood culture based diagnostics. This gives clinicians actionable information much earlier than was previously possible, allowing them to make more informed treatment plans for escalation or de-escalation of antimicrobial therapy. For example the T2Bacteria Panel covers 90% of the ESKAPE pathogens, which are particularly pathogenic and dangerous bacteria.
In addition, earlier this year, the Company announced that the FDA granted Breakthrough Device designation for the T2Resistance Panel, a diagnostic panel that can detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample, without the wait for blood culture.
About T2 Biosystems T2 Biosystems, a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, T2Candida® Panel, and T2Bacteria® Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including products for the detection of additional species and antibiotic resistance markers of sepsis pathogens, and tests for Lyme disease.
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