T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the
development of innovative diagnostic products to improve patient
health, today announced that Henry Ford Health System published the
clinical impact of the T2Candida Panel in The Journal of
Antimicrobial Stewardship. The study, titled “T2 Magnetic Resonance
Assay Improves Timely Management of Candidemia,” compared the
management of candidemic patients before and after the
implementation of the T2Candida Panel and was designed to evaluate
time to appropriate therapy. Patients tested with the T2 Magnetic
Resonance (T2MR) platform were treated in a median of 5 hours, a
more than 8-fold reduction as compared to that based on blood
culture, which delayed appropriate therapy by a median of 44 hours.
This speed advantage demonstrates that the T2MR platform is a
valuable clinical tool to aid antifungal stewardship’s goal to
deliver timely antifungal therapy for infected patients.
“This technology has shown it can expedite the detection of
candidemia,” said Henry Ford study co-author Rachel Kenney, PharmD.
“As a result, patients receive more prompt and appropriate
antifungal therapy.”
In addition to speed, the use of the T2MR platform provided
increased certainty to the identification of Candida infections.
Consistent with the performance of blood culture and T2MR published
in other studies, the Candida species was definitively identified
in 93% of patients after implementation of T2MR and in only 57% of
patients prior to implementation of T2MR. Prior to implementation
of the T2Candida Panel, the only diagnostic tests used at Henry
Ford were blood culture and beta-D-glucan (BDG).
“In our inaugural publication, we are excited to highlight
innovative work done by antimicrobial stewardship clinicians to
provide optimal care to their patients and be better stewards of
antimicrobials,” said Eric Wenzler, PharmD, editor of the Journal
of Antimicrobial Stewardship. “Henry Ford’s use of
the T2Candida assay to significantly reduce time to
appropriate antifungal therapy is an important advance in rapid
diagnostics, patient care, and antifungal stewardship.”
The authors also identified an additional clinically relevant
improvement in patient outcomes after the implementation of T2MR: a
significant reduction of Candida ocular involvement from 30% to 12%
was observed. The authors point out this could be associated with
improved sensitivity of T2MR or due to improved timeliness of
patient management by T2MR.
Although the study was not adequately powered to evaluate
reduction in patient mortality rates, the authors note that
appropriately treating patients within 24 hours of the onset of
disease is proven to reduce mortality rates from 41% to below 16%.
T2MR is the only diagnostic method presented in this study with the
speed and accuracy necessary to enable therapeutic decisions that
achieve this reduction in mortality.
“I expected that T2MR platform’s direct-from-whole-blood
technology would be the biggest breakthrough in candidemia
management in decades and these clinical data demonstrate the
promise of culture independent diagnostics,” said Michael A.
Pfaller, M.D., Emeritus Professor, University of Iowa and Clinical
Advisor, T2 Biosystems. “The T2MR platform is improving patient
care, antimicrobial stewardship, and hospital finances today - and
the positive impact for hospitals should only grow as new tests
become commercially available.”
The Journal of Antimicrobial Stewardship paper was
published online
at: http://www.jantimicrobialstewardship.org/issues/.
About the sepsis-causing pathogen Candida
Candida is one of the deadliest sepsis-causing pathogens with
a startling mortality rate of approximately 40% among patients
receiving current standard of care. It is one of the leading
hospital-acquired bloodstream infections in the United States and
half of Candida infections are misdiagnosed as being
negative by blood culture. The patient and economic impacts
of Candida are tremendous: patients average 40 days in
the hospital at a cost of $130,000 each.
About T2 Biosystems T2 Biosystems, an emerging
leader in the field of in vitro diagnostics, is dedicated to saving
lives and reducing the cost of healthcare by empowering clinicians
to effectively treat patients faster than ever before. T2
Biosystems is focused on addressing critical unmet needs in
healthcare starting with sepsis, one of the deadliest and most
expensive conditions in hospitals today. The T2Sepsis SolutionTM is
a unique approach that combines the standard of care for the
management of sepsis patients with T2 Biosystems’ products,
including the T2Dx® Instrument and T2Candida® Panel, and the
T2Bacteria® Panel, which is commercially available in Europe and
other countries that accept the CE Mark and available for research
use only in the U.S. Powered by the proprietary T2 Magnetic
Resonance technology, or T2MR®, the T2Sepsis Solution is proven to
deliver better patient care and greater cost savings. Hospital
customer experience has demonstrated faster time to effective
treatment, shortened ICU and hospital lengths of stay, reduced use
of unnecessary antifungals, and millions of dollars in savings. T2
Biosystems has an active pipeline of future sepsis products
including additional species and antibiotic resistance, as well as
tests for Lyme disease and hemostasis. For more information, please
visit www.t2biosystems.com.
About the Journal of Antimicrobial
StewardshipThe Journal of Antimicrobial Stewardship
(JAMS) is the only exclusive journal devoted to the
advancement of antimicrobial stewardship. The open-access journal
publishes quarterly peer-reviewed articles on a variety of topics
that pertain to antimicrobial stewardship including clinical
microbiology, rapid diagnostic tests, pharmacoeconomics, disease
state-based stewardship interventions and the evaluation of current
and novel therapies that promote optimal infectious diseases
practices in a variety of settings and institutions.
JAMS publishes high-quality original research articles, review
articles, editorial commentaries, and challenging patient
scenarios. The aim of the Journal of Antimicrobial
Stewardship is to provide timely, informative and innovative
research articles on topics related to antimicrobial stewardship
and infectious diseases pharmacotherapy. The goal of the Journal is
to catalyze the change required to improve patient outcomes through
the promotion of optimal antimicrobial stewardship practices. For
more information about the Journal, please visit
jantimicrobialstewardship.org or follow @JAMS_journal on Twitter.
To register as an author and/or reviewer, visit the JAMS editorial
manager at ojs.jantimicrobialstewardship.org. For any inquires,
contact the Journal at editor@jantimicrobialstewardship.org.
Forward-Looking Statements This 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 regarding ,
product pipeline, anticipated product benefits, goals and strategic
priorities, product expansion or opportunities, growth expectations
or targets and FDA clearance, 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, 2016, filed with the U.S.
Securities and Exchange Commission, or SEC, on March 15, 2017, 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, one should
not 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.
Company Contact:Darlene Deptula-Hicks, T2
BiosystemsSVP & Chief Financial
Officerddeptula@t2biosystems.com603-553-5803
Media Contact:Amy Phillips, Feinstein Kean
Healthcare amy.phillips@fkhealth.com412-327-9499
Investor Contact:Chris Brinzey, Westwicke
Partners chris.brinzey@westwicke.com339-970-2843
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