Publication in Annals of Internal Medicine® Reveals T2Bacteria® Panel as the First Direct-from-Blood, Non-Culture Test tha...
May 14 2019 - 7:00AM
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.
Media Contact: Gina Kent, Vault
Communicationsgkent@vaultcommunications.com 610-455-2763
Investor Contact: Zack Kubow, W2O Group
zkubow@w2ogroup.com 415-658-6436
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