Publication in Annals of Internal Medicine® Reveals T2Bacteria® Panel as the First Direct-from-Blood, Non-Culture Test that Rapidly Diagnoses Bacterial Bloodstream Infections
LEXINGTON, Mass., May 14, 2019 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the development of innovative diagnostic products for critical unmet needs in healthcare, today announced that results from a pivotal trial were published online in the Annals of Internal Medicine® journal. The study, “Performance of the T2Bacterial Panel for Diagnosing Bloodstream Infections. A Diagnostic Accuracy Study,” demonstrated decisive evidence for the first direct-from-blood, non-culture test cleared by the U.S. Food and Drug Administration (FDA) for the diagnosis of bloodstream infections by multiple bacteria.
The T2Bacteria® Panel received FDA clearance in May 2018 and is the first and only FDA-cleared test to identify sepsis-causing bacteria directly from whole blood without the wait for blood culture, which currently takes 1 to 5 or more days and is the current standard of care for diagnosing bloodstream infections (BSIs). The panel delivers results in three to five hours for the most common ESKAPE bacteria Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa and Escherichia coli.
“With a blood culture, it typically takes days to cultivate organisms to learn if a patient has bacteremia and, if so, what bacteria is causing the infection. Additionally, blood cultures are not always sensitive enough to pick up the presence of bacteria in the bloodstream, such as when the patient has already been started on antibiotics,” said M. Hong Nguyen, M.D., University of Pittsburgh Department of Medicine, and lead author of the study. “There are well known limitations with relying solely on blood cultures. Technology that can deliver pathogen results in a matter of hours from initial blood draw, a capability which is unlike any other FDA-cleared device in the market today, can allow clinicians to approach initial clinical BSI treatment in a more informed way.”
The pivotal data exhibited the advantages that the T2Bacteria® Panel, which runs on the T2Dx® Instrument, can provide in diagnosing BSIs.
Key Study Findings The multi-center study enrolled and collected blood specimens from 1,427 patients who had a blood culture ordered as part of the standard of care. In the pivotal trial, the T2Bacteria® Panel and T2Dx® Instrument demonstrated:
-- Blood cultures took between 32 and 111 hours to identify pathogens whereas the T2Bacteria® Panel took 3.6 to 7.7 hours to do so. -- In 78% of probable or possible BSIs, subjects had blood culture-negative/T2Bacteria positive results despite treatment with active antibiotics. -- 24 hours after blood draw, 20% of patients with blood culture-positive/T2bacteria-positive results were still not receiving effective therapy. -- The T2Bacteria® Panel had a 99.7% negative predictive value. -- The T2Bacteria® Panel had overall sensitivity of 89.7% per subject and per assay. -- The T2Bacteria® Panel had overall specificity of 89.5% per subject and 97.8% per assay.
“This study clearly demonstrates that there are shortcomings with the sensitivity and speed of blood culture results and that the T2Bacteria® Panel can shorten the time to appropriate antibiotic treatment in patients, a huge step in the right direction for improving clinical outcomes. Timely administration of appropriate treatment might also help reduce hospital costs, such as by reducing length of stay, another added benefit to this technology,” said Nguyen. “Now that we have this information, it’s crucial for clinicians to come together to understand how to incorporate this technology into rational patient management and antibiotic stewardship strategies.”
The T2Bacteria® Panel is part of a suite of products including the T2Candida® Panel—the first and only direct-from-blood detection panel that provides same-day results for the most clinically relevant fungi. For efficiency, both panels run on the same T2Dx® Instrument, a fully automated, walk away, clinical multiplex benchtop diagnostic system capable of running tests directly from whole blood.
“We are pleased that the results from our 1,427 patient pivotal study of the T2Bacteria Panel are now available for clinicians,” said Dr. Sandy Estrada, vice president medical affairs of T2 Biosystems. “Since the completion of this study in August 2017, we have secured FDA clearance and launched the T2Bacteria Panel in the U.S. and Europe. The initial commercial experience appears to be aligned with the strong results demonstrated in the pivotal study, as several customers have shared case studies of the T2Bacteria Panel providing actionable test results that improved patient care and several have developed and implemented patient selection criteria for the ICU, oncology units and the Emergency Department. We continue to engage with clinicians, stewardship teams and laboratory personnel at hospitals as they expand utilization of the T2Bacteria Panel and develop independent data examining its clinical and cost-savings benefits, similar to what we have already seen with the T2Candida Panel.”
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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