T2 Biosystems Receives Funding from BARDA to Advance Technology for Diagnosis and Treatment of Bloodstream Infections
11 September 2019 - 11:30PM
T2 Biosystems, Inc. (NASDAQ:TTOO) an emerging leader in the
development and commercialization of innovative medical diagnostic
products for critical unmet needs in healthcare, announced today
that it has been awarded a milestone-based contract of initial
value of $6 million with a potential value of up to $69 million, if
all contract options are exercised, from the Biomedical Advanced
Research and Development Authority (BARDA), within the Office of
the Assistant Secretary for Preparedness and Response (ASPR) at the
U.S. Department of Health and Human Services’ (HHS).
The contract will enable a significant expansion of the
Company’s current portfolio of diagnostics for sepsis-causing
pathogens and antibiotic-resistance genes, which are designed to
improve patient outcomes and reduce the growing threat of
antimicrobial resistance. This contract will fund development
through U.S. Food & Drug Administration (FDA) submission of new
direct-from-blood diagnostic panels that will be run on the T2Dx
Instrument and the development of a next generation T2Dx
Instrument:
- The first panel developed will be a direct-from-blood panel for
detection of biothreat pathogens, including threats such as B.
anthracis, F. tularensis, Burkholderia spp., Y. pestis, R.
prowazekii, and toxin genes.
- The second panel is expected to cover 99% of all bloodborne
bacterial infections by means of ≥36 reported results, which
include pan-Gram positive and pan-Gram negative results (detecting
>250 species), in addition to the bloodborne antibiotic
resistant threats identified by the Centers for Disease Control and
Prevention (CDC).
- Along with the new panels, the BARDA award supports the
development of a next-generation high-throughput
instrument.
“By providing same-day results, T2 Biosystems’ existing
technology has made a significant impact on therapy decisions, and
this next generation of innovations has the potential to expand on
this progress,” said Dr. Minh-Hong Nguyen, Professor of Medicine
and Clinical & Translational Science Institute, University of
Pittsburgh, and Director, Transplant Infectious Diseases and
Antimicrobial Management Program of the University of Pittsburgh
Medical Center. “With much more comprehensive coverage of the
causative pathogens of bloodstream infections, this technology has
the potential to rapidly and accurately diagnose and identify
common bacterial causes of BSIs, and allow physicians to get
patients started on appropriate therapy much sooner. It is a
potential game changer for the way we practice medicine.”
“We are incredibly grateful to BARDA for this contract, which
will allow us to continue to innovate, advance our product
pipeline, and look forward to our public-private partnership with
BARDA,” said John McDonough, chairman and chief executive officer
of T2 Biosystems. “More importantly, we are looking forward to the
opportunity to develop more technology that will truly transform
the way bloodstream infections are diagnosed and managed and to
continue to provide new advanced tools for improved antibiotic
stewardship so that we can help save more lives and provide
clinicians with the information they need to help prevent
sepsis.”
About T2 BiosystemsT2 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, which was recently
announced as the first and only in-vitro diagnostic test to receive
approval for a New Technology Add-on Payment (NTAP) by CMS, 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.
This project has been funded in whole or in part with Federal
funds from the Department of Health and Human Services; Office of
the Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority, under Contract No.
75A50119C00053.
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
Communicationsgkent@vaultcommunications.com 610-455-2763
Investor Contact:Zack Kubow, W2O
Groupzkubow@w2ogroup.com415-658-6436
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