T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens and antibiotic resistance
genes, today announced participation in the NIH-funded
Antibacterial Resistance Leadership Group (ARLG) pilot study for
pneumonia patients. The Pneumonia Direct Pilot study is a
prospective, observational, diagnostic, feasibility study to
determine the accuracy of multiple pathogen- and host-directed
tests for the diagnosis of ventilator-associated pneumonia (VAP).
Under the direction of Kimberly Hanson, M.D., University of Utah,
the study seeks to explore new approaches for diagnosing VAP along
with more comprehensive detection of antibiotic-resistant
infections. The feasibility design is intended to inform future
interventional studies that will investigate the clinical impact of
combined pathogen and host-directed testing approaches.
“I am elated that the innovative research
leaders of Antibacterial Resistance Leadership Group are
collaborating with T2 Biosystems to evaluate direct-from-blood
diagnostic technology for the management of patients with
pneumonia. This study will explore whether the combined diagnostic
testing can successfully provide more targeted antimicrobial
therapy, strengthen stewardship, and improve outcomes,” said Dr.
Thomas J. Walsh, Director of the Center for Innovative Therapeutics
and Diagnostics (citdx.org) and member of the T2 Biosystems
Scientific Advisory Board.
In the pilot study, the FDA-cleared T2Bacteria®
Panel and the T2Resistance® Panel, included as one of the pathogen
directed platforms, will be evaluated for the ability to rapidly
detect infections in the blood currently missed by conventional
methods. The T2 sample testing for the multi-center study will be
performed at Johns Hopkins Medicine laboratories.
The extremely low level of detection by T2
Biosystems’ technology (“T2MR”) in whole blood (1 – 11 CFU/mL) has
been effective in detecting secondary infections. Most recently, a
2022 publication1 in the journal Microbiology Spectrum evaluated
the use of T2 Biosystems’ sepsis tests in COVID-19 patients and
found “without the additional use of T2MR, 13.3% of candidemia and
10% of bacterial superinfections would have been missed.”
About Ventilator-associated pneumonia
(VAP)Ventilator-associated pneumonia (VAP) is one of the
most common nosocomial infections complicating critical care
medicine. Recent studies have reported that VAP affects between
5-40% of patients intubated for more than 2 days, with significant
variation by county, intensive care unit (ICU), and criteria used
to define the disease2. Patients who develop VAP have prolonged
durations of mechanical ventilation, increased lengths of ICU stay,
and higher hospital costs3. Poor outcomes are due, at least in
part, to difficulties in making a diagnosis of VAP, which in turn
delays the initiation of appropriate antibiotic therapy4. The
clinical criteria suggestive of VAP are non-specific and standard
microbiologic testing does not definitively separate airway
colonizers from invasive pathogens. The resultant diagnostic
uncertainty is a major driver of unnecessary antibiotic use and
potentially antimicrobial resistance in the ICU5,6. Furthermore,
selecting effective empiric therapy for VAP is also complicated
because multidrug-resistant pathogens may be isolated in
early-onset VAP (i.e., within the first 4 days of hospitalization)
as well as in late-onset cases7.
About T2 BiosystemsT2
Biosystems, a leader in the rapid detection of sepsis-causing
pathogens and antibiotic resistance genes, 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, the T2Bacteria®
Panel, the T2Candida® Panel, the T2Resistance® Panel, and the
T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic
Resonance (T2MR®) technology. T2 Biosystems has an active pipeline
of future products, including the T2Biothreat™ Panel, the T2Cauris™
Panel, and T2Lyme™ Panel, as well as next-generation products for
the detection of bacterial and fungal pathogens and associated
antimicrobial resistance markers. For more information, please
visit www.t2biosystems.com.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
All statements contained in this press release that do not relate
to matters of historical fact should be considered forward-looking
statements, including, without limitation, statements about the
ability of the Company’s product to provide more targeted
antimicrobial therapy, strengthen stewardship, and improve
outcomes, as well as statements that include the words “expect,”
“intend,” “plan,” “believe,” “project,” “forecast,” “estimate,”
“may,” “should,” “anticipate,” and similar statements of a future
or forward looking nature. These forward-looking statements are
based on management’s current expectations. These statements are
neither promises nor guarantees, but involve known and unknown
risks, uncertainties and other important factors that may cause
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements, including,
but not limited to, (i) any inability to (a) realize anticipated
benefits from commitments, contracts or products; (b) successfully
execute strategic priorities; (c) bring products to market; (d)
expand product usage or adoption; (e) obtain customer testimonials;
(f) accurately predict growth assumptions; (g) realize anticipated
revenues; (h) incur expected levels of operating expenses; or (i)
increase the number of high-risk patients at customer facilities;
(ii) failure of early data to predict eventual outcomes; (iii)
failure to make or obtain anticipated FDA filings or clearances
within expected time frames or at all; or (iv) the factors
discussed under Item 1A. “Risk Factors” in the company’s Annual
Report on Form 10-K for the year ended December 31, 2022, filed
with the U.S. Securities and Exchange Commission, or SEC, on March
31, 2023, and other filings the company makes with the SEC from
time to time. These and other important factors could cause actual
results to differ materially from those indicated by the
forward-looking statements made in this press release. Any such
forward-looking statements represent management’s estimates as of
the date of this press release. While the company may elect to
update such forward-looking statements at some point in the future,
unless required by law, it disclaims any obligation to do so, even
if subsequent events cause its views to change. Thus, no one should
assume that the Company’s silence over time means that actual
events are bearing out as expressed or implied in such
forward-looking statements. These forward-looking statements should
not be relied upon as representing the company’s views as of any
date subsequent to the date of this press release.
Research discussed in this publication is
supported in part by the ARLG Grant from the National Institute of
Allergy and Infectious Diseases (NIAID) part of the National
Institutes of Health (NIH) under Award Number UM1AI104681. The
content is solely the responsibility of the authors and does not
necessarily represent the official views of the National Institutes
of Health. For more information about this trial, visit
ClinicalTrials.gov and search identifiers NCT NCT06181669.
References:
1 Seitz T, Holbik J, Hind J, Gibas G, Karolyi M, Pawelka E,
Traugott M, Wenisch C, Zoufaly A. Rapid Detection of Bacterial and
Fungal Pathogens Using the T2MR versus Blood Culture in Patients
with Severe COVID-19. Microbiol Spectr. 2022 Jun 29;10(3):e0014022.
doi: 10.1128/spectrum.00140-22. Epub 2022 Jun 13. PMID: 35695564;
PMCID: PMC9241933.
2 Papazian L, Klompas M, Luyt CE. Ventilator-associated
pneumonia in adults: a narrative review. Intensive Care Med. May
2020;46(5):888-906. doi:10.1007/s00134-020-05980-0
3 Safdar N, Dezfulian C, Collard HR, Saint S. Clinical and
economic consequences of ventilator-associated pneumonia: a
systematic review. Crit Care Med. Oct 2005;33(10):2184-93.
doi:10.1097/01.ccm.0000181731.53912.d9
4 Kuti EL, Patel AA, Coleman CI. Impact of inappropriate
antibiotic therapy on mortality in patients with
ventilator-associated pneumonia and blood stream infection: a
meta-analysis. Journal of critical care. Mar 2008;23(1):91-100.
doi:10.1016/j.jcrc.2007.08.007
5 Nussenblatt V, Avdic E, Berenholtz S, et al.
Ventilator-Associated Pneumonia: Overdiagnosis and Treatment Are
Common in Medical and Surgical Intensive Care Units. Infection
Control & Hospital Epidemiology. 2014;35(3):278-284.
doi:10.1086/675279
6 Klompas M. Does this patient have ventilator-associated
pneumonia? Jama. Apr 11 2007;297(14):1583-93.
doi:10.1001/jama.297.14.1583
7 Khan S, Liu J, Xue M. Transmission of SARS-CoV-2, Required
Developments in Research and Associated Public Health Concerns.
Front Med (Lausanne). 2020;7:310. doi:10.3389/fmed.2020.00310
Investor Contact: Philip Trip Taylor, Gilmartin
Group ir@T2Biosystems.com 415-937-5406
T2 Biosystems (NASDAQ:TTOO)
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T2 Biosystems (NASDAQ:TTOO)
過去 株価チャート
から 5 2023 まで 5 2024