T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the
development of innovative diagnostic products to improve patient
health, today announced new data presented during the IDWeek 2017
Conference on the T2Sepsis SolutionTM, which includes the
T2Bacteria® Panel, commercially available in Europe today and
recently submitted to the FDA in the United States for market
clearance, and the T2Candida® Panel, commercially available in both
the United States and Europe, coupled with the current standard of
care of providing broad spectrum antibiotics to symptomatic
patients.
“A growing dataset continues to highlight the
strong performance of the T2MR platform. The diagnostic superiority
of the T2Candida Panel over blood culture has been proven in
multiple studies and new data demonstrate the prognostic potential
of this technology,” said Cornelius J. Clancy, M.D., Associate
Professor of Medicine, Director, Mycology Program, University of
Pittsburgh; Chief, Infectious Diseases Section - VA Pittsburgh
Healthcare System. “With the addition of the T2Bacteria Panel, once
FDA-cleared, I expect most hospitals will want to offer this
technology to their clinicians for routine clinical use.”
The T2MR platform is detecting infections
missed by blood culture and demonstrates consistently strong
performance, as reported by Dr. Clancy in the panel
presentation “T2Sepsis Solution: The Impact of Direct from Whole
Blood Diagnostics on the Management of Bloodstream Infections.”
- T2Candida Panel identified 37 cases of Candida infections
missed by companion blood cultures for patients receiving
antifungal therapy in a multi-center DIRECT2 study.
- Findings suggest that T2Candida is more sensitive than blood
culture, especially in the presence of antifungal treatment, and a
more effective diagnostic tool for patients treated with
pre-emptive or empiric antifungal therapy.
- Accumulating data for T2Candida’s performance in clinical
practice demonstrate a sensitivity at about 90% and specificity
ranging from 98% to 99%.
The T2Bacteria Panel investigational data
provide insight into the compelling clinical value for hospitals in
the emergency department and inpatient care, as reported
by Glen T. Hansen, Ph.D., Director of Clinical Microbiology and
Molecular Diagnostics, Hennepin County Medical Center (HCMC) in a
panel presentation.
- HCMC patient analysis suggests the T2Bacteria Panel will cover
between 85% and 90% of patient cases that come into the hospital
through the emergency department.
“I believe the T2Sepsis Solution is the ‘holy
grail’ of bloodstream infection diagnostics. No other product can
give me virtually hands-free, automated pathogen detection and
identification directly from a whole blood sample,” said Dr.
Hansen. “With the T2MR platform, I expect my laboratory will get
accurate, actionable results to clinicians faster, so patients get
on the right treatment earlier when it matters most.”
In addition, the following are highlights from
poster presentations at IDWeek 2017:
- New data on the ability of the T2MR platform to detect
the superbug Candida auris was presented by T2
Biosystems. • The T2MR
platform successfully identified Candida auris in patient samples
at La Fe University and Polytechnic Hospital in Spain.
• Average time to identification with the T2MR platform
was less than 5 hours while time to positive blood culture ranged
from 19 to 83 hours prior to subsequent identification.
- The T2MR platform detected infections missed by blood
culture and led to the avoidance or de-escalation of unnecessary
antifungal therapy at Huntsville
Hospital. • The T2Candida
Panel demonstrated overall sensitivity of 94.4% and identified 26
proven infections that were not detected by blood culture.
• Negative T2Candida Panel results contributed to the
avoidance or de-escalation of antifungal therapy in 64% of these
negative patients. • Negative T2Candida results
decreased the average duration of micafungin therapy by 2.1
days. • The authors concluded that the T2Candida
Panel demonstrated greater sensitivity for Candida infections and
generated results much faster than blood culture.
- The T2MR platform led to reduced use of antifungals and
cost savings at Robert Wood Johnson
Hospital. • Antifungal
therapy was avoided or ceased in 67% of patients with a negative
T2Candida result and resulted in cost savings due to reduced use of
antifungal drugs.
- The T2MR platform identified infections missed by blood
culture and reduced the time to initiation of therapy by 1.5 days
at the University of Alabama at Birmingham
Hospital. • The authors
concluded that the T2Candida Panel demonstrated excellent
sensitivity (86%) in a real world setting.
• T2Candida identified 23 patients that blood culture
missed. • Rapid T2Candida test results led to
accelerating the time to treat patients with the right targeted
therapy by 1.5 days.
“Clinical and practical use of the T2MR platform
continues to grow, and the impact is being shared by customers who
are experiencing the value of the platform’s superior accuracy and
time to result when compared to blood culture,” said John
McDonough, president and chief executive officer of T2
Biosystems. “IDWeek presented an excellent opportunity to
share the powerful data and case studies around the T2Candida and
T2Bacteria Panels, which sets the stage nicely for our commercial
expansion of the T2Sepsis Solution over the next year.”
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.
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
Healthcareamy.phillips@fkhealth.com412-327-9499
Investor Contact:Chris Brinzey, Westwicke
Partners chris.brinzey@westwicke.com 339-970-2843
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