T2 Biosystems Introduces New Clinical Data and Updates Regarding Expanding Capabilities of its Rapid Diagnostic Technology a...
June 20 2019 - 7:30AM
T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the
development of innovative medical diagnostic products for critical
unmet needs in healthcare, will share multiple updates regarding
the clinical utility of its expanding portfolio of groundbreaking
rapid diagnostics and technology during ASM Microbe 2019 in San
Francisco, CA from June 19 to 24.
“The T2Bacteria® and T2Candida® panels are the
first-and-only FDA cleared tests that can provide
direct-from-blood, rapid diagnostics for patients suspected of
blood stream infection or sepsis. This patent-protected
technological innovation is a major accomplishment, particularly
when considering the decades of attempted development efforts from
over a half dozen other companies that did not yield FDA cleared
tests. Since introducing our T2Bacteria Panel at last year’s
meeting, we are proud to share that we’ve altered the course of
clinical treatment in meaningful ways, making a significant impact
on healthcare facilities and the patients they treat,” said John
McDonough, president and chief executive officer of T2 Biosystems.
“We look forward to our time at ASM Microbe 2019 as an opportunity
to connect with the world’s leading microbiologists and communicate
this impact, along with our plans for continuing on this disruptive
path as we work to address unmet needs related to sepsis prevention
in today’s healthcare environment.”
Throughout the show, T2 Biosystems will offer attendees multiple
opportunities to experience new data that underscore the benefits
experienced by facilities who have adopted T2 technology. Tom
Lowery, PhD, chief scientific officer, T2 Biosystems, will present
an Industry Education Workshop, Rapid, Direct-from-Blood
Diagnostics that Enable Changes in Clinical Decisions, on Friday,
June 21 from 12:00 – 12:45 pm in Theater North in the Exhibit Hall
of The George R. Moscone Convention Center.
The presentation will highlight clinical updates regarding
current and future applications of T2 technology, including:
- T2Bacteria provides actionable clinical
information: New T2Bacteria Panel clinical data being
generated by independent commercial users shows its ability to
benefit tested patients in the emergency department by providing
information that leads to more rapid time to delivery of effective
therapy, de-escalation of unnecessary therapy, and helping avoid
premature discharge and readmission to the emergency
department.
- Meta-analysis of 70 studies highlights significant
challenges of empiric therapy (without T2Bacteria and
T2Candida): 46.5% of patients are on inappropriate
antibiotic therapy with empiric therapy alone, while >90% are on
effective therapy after accurate species identification, such as
provided by T2Bacteria and T2Candida.
- T2Bacteria clinical patient selection algorithms
demonstrate significant clinical impact: Dr. Lowery will
review T2Bacteria patient selection algorithms implemented by
T2Bacteria customers and summarize emerging clinical utility data
of 120 clinical cases demonstrating significant clinical impact. He
will also detail multiple cases demonstrating the impact and
potential impact of T2Bacteria on clinical outcomes.
- T2Resistance™ Panel provides ≥
two day time advantage compared to conventional methods:
The T2Resistance Panel, which was recently granted Breakthrough
Device designation by the FDA, is designed to detect 13 resistance
genes from both gram-positive and gram-negative pathogens direct
from blood. Initial data demonstrates T2Resistance identifies these
resistance genes with an average time of 5.3 hours compared to an
average of 30 hours (and up to 95 hours) with conventional methods.
The T2Resistance Panel is expected to be available for research use
only (RUO) in the U.S. and receive CE-Mark for commercial
availability in Europe by the end of 2019.
- T2MR® Technology has
the potential to provide coverage for ≥99% of bloodstream
infections: Dr. Lowery will present feasibility data
demonstrating that the T2MR Technology has the capability to
potentially detect >250 pathogen species, which would cover ≥99%
of blood-borne pathogens responsible for bloodstream infections and
sepsis. It has also demonstrated the ability to potentially detect
resistance markers for all blood-borne antibiotic resistance
threats identified by the Centers for Disease Control (CDC). These
diagnostic capabilities could allow the Company to develop a panel
that provides comprehensive coverage of bloodstream
infections.
The Company will also participate in an Industry & Science
Tech Talk on Saturday, June 22 at 11:00 am in the Innovation Zone
(Booth #4811) and host multiple in-booth presentations, including
Rapid Culture Independent Detection of Resistance Genes Direct from
Whole Blood by T2MR® throughout the show in Booth #1443, where
its products will be on display for the duration of the
meeting.
T2 Biosystems is the company behind the T2Bacteria Panel, the
first and only FDA-cleared test to identify sepsis-causing
bacterial pathogens directly from whole blood in 3 to 5 hours
without the need to wait for blood culture, allowing patients to be
placed on targeted antibiotic therapy faster. The T2Bacteria Panel
is one of several panels that are approved or in development that
are run on the Company’s T2Dx® Instrument, which is powered by
miniaturized magnetic resonance (T2MR®) technology.
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.
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 regarding additional
patients, timing of testing patients, anticipated product benefits,
strategic priorities, product expansion or opportunities, growth
expectations or targets, timing of FDA filings or clearances and
anticipated operating expenses, 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, 2018, filed with the U.S.
Securities and Exchange Commission, or SEC, on March 14, 2019, 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.
Media Contact: Gina Kent, Vault
Communications gkent@vaultcommunications.com 610-455-2763
Investor Contact: Zack Kubow, W2O Group
zkubow@w2ogroup.com 415-658-6436
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