T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today the publication of three new, peer-reviewed studies that demonstrate the clinical value of the use of the T2 Biosystems’ products, also referred to as T2 Magnetic Resonance Technology (T2MR®). T2 Biosystems’ sepsis products are CE marked, and include the only FDA cleared products able to quickly and accurately detect sepsis-causing pathogens within adult patient blood samples without the need to wait hours for a positive blood culture. The studies were conducted in Europe and published in the Journal of Clinical Microbiology, Microbiology Spectrum and the Journal of Fungi.
“We are pleased with the growing number of publications with clinical evidence supporting the value proposition of our sepsis panels. Given the mounting evidence of additional clinical utility, we are exploring expansion of product claims through future regulatory submissions,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “The growing awareness of the benefits of our technology can help T2 Biosystems positively impact the lives of more patients, advance the standard of care, and drive continued product adoption.”
Study Highlights
Combining T2Bacteria and T2Candida Panels for Diagnosing Intra-Abdominal Infections: A Prospective Multicenter Study (2022)
Authors: Anders Krifors, Måns Ullberg, Markus Castegren, Johan Petersson, Ernesto Sparrelid, Volkan Özenci and Ola Blennow
Journal: Journal of Fungi 2022, 8, 832
A study conducted at the Karolinska University Hospital in Stockholm, Sweden, that combined T2Bacteria and T2Candida to diagnose Intra-Abdominal Infection (IAI) in surgical patients admitted to the ICU or high dependency unit found:
- Ability to detect more infections: T2Bacteria and T2Candida detected more clinically confirmed cases of IAI than blood culture.
- Faster Targeted Therapy: 15% of blood culture negative and T2Bacteria positive cases were receiving inappropriate antimicrobial therapy at the time of sampling.
- Fast and accurate detections: T2Bacteria and T2Candida were fast and accurate in diagnosing on-panel bloodstream infections and were able to detect culture-negative IAI and intra-abdominal candidiasis (IAC).
Effective Rapid Diagnosis of Bacterial and Fungal Bloodstream Infections by T2 Magnetic Resonance Technology in the Pediatric Population (2022)
Authors: B. Lucignano, V. Cento, M. Agosta, F. Ambrogi, S. Albitar-Nehme, L. Mancinelli, G. Mattana, M. Onori, F. Galaverna, L. Di Chiara, T. Fragasso, R. Bianchi, F. Tortora, C. Auriti, A. Dotta, C. Cecchetti, S. Perdichizzi, M. Raponi, A. Onetti Muda, S. Nerini Molteni, A. Villani, F. Locatelli, C. Federico Perno, P. Bernaschia
Journal: American Society for Microbiology, Journal of Clinical Microbiology
A 754 patient retrospective research study conducted at the Bambino Gesù hospital in Rome, Italy, that analyzed the diagnosis of bacterial and fungal bloodstream infections in the pediatric population found:
- Faster Targeted Therapy: Patients suspected of bacterial or fungal bloodstream infections that were tested with T2Bacteria or T2Candida received targeted therapy 61.3 hours or 121.8 hours faster compared to blood culture, respectively.
- Higher Detection Rate: T2Bacteria and T2Candida detected 79 additional probable or possible bacterial bloodstream infections and 6 additional probable or possible fungal bloodstream infections in pediatric patients that were missed by blood culture.
Rapid Detection of Bacterial and Fungal Pathogens Using the T2MR versus Blood Culture in Patients with Severe COVID-19 (2022)
Authors: Tamara Seitz, Johannes Holbik, Julian Hind, Georg Gibas, Mario Karolyi, Erich Pawelka, Marianna Traugott, Christoph Wenisch, Alexander Zoufalya
Journal: Microbiology Spectrum
A study conducted at the Klink Favoriten hospital in Vienna, Austria, reported several highlights regarding usage of T2 Biosystems’ products to detect COVID-19 superinfections in ICU patients.
- Faster Targeted Therapy: The median time to therapy change with T2 panels was more than 52 hours faster compared to blood culture. The authors noted “without the additional use of T2MR, 13.3% of candidemia and 10% of bacterial superinfections would have been missed.”
- Faster Time to Detection: Positive results for COVID-19 with T2Bacteria were available in 4.3 hours, compared to a mean time of 41.5 hours for the standard of care. Positive results for COVID-19 with T2Candida were available in 5 hours compared to a mean time of 85.6 hours for the standard of care. A negative result for T2MR was available in 4.7 hours compared to a mean time of 177.3 hours for the standard of care.
- Sensitivity and Specificity: T2 Biosystems’ products detected 100% of species on the panel.
- Impact on Infections: T2 Panel targets covered and detected 71.4% of all pathogens causing infection.
