HHS and the Cohen Foundation Name T2 Biosystems a Phase 1 Winner in LymeX Diagnostics Prize
November 07 2022 - 8:30AM
T2 Biosystems, Inc. (NASDAQ:TTOO) a leader in the rapid detection
of sepsis-causing pathogens and antibiotic resistance genes,
announced today that the U.S. Department of Health and Human
Services (“HHS”) and the Steven & Alexandra Cohen Foundation
(“Cohen Foundation”) have selected T2 Biosystems as a Phase 1
winner in the LymeX Diagnostics Prize, a LymeX Innovation
Accelerator (“LymeX”) prize competition to accelerate the
development of Lyme disease diagnostics. As a Phase 1 winner, T2
Biosystems will receive $100,000 and an invitation to participate
in a second phase.
The current two-tier serological testing system
relies on the presence of antibodies and can only be used
accurately four to six weeks after infection. The LymeX Diagnostics
Prize’s open innovation model is accelerating discovery and
development by offering no-strings-attached funding alongside
exclusive access to key resources and collaboration
opportunities—helping innovators take their solutions from concept
to the healthcare market.
“We appreciate the leadership from HHS and the
Cohen Foundation to advance next generation Lyme diagnostics, and
we are grateful to receive this support to advance our T2Lyme Panel
for the detection of early Lyme disease,” stated John Sperzel,
Chairman and CEO of T2Biosystems. “We believe the T2Lyme Panel may
allow clinicians to ensure patients receive appropriate therapy
faster, and prevent the negative impact of a delay in the delivery
of appropriate therapy and the overuse of antibiotics.”
From May to August 2022, Phase 1 received 52
solutions for detecting active Lyme disease infections in people.
Solutions incorporated techniques such as radiology imaging,
genomics sequencing, and microfluidics; submissions also translated
approaches used in diagnosing other infectious diseases, including
COVID-19. Technical reviewers initially evaluated this highly
competitive field, and then the competition judging panel assessed
submissions according to official evaluation criteria.
At the discretion of HHS and the Cohen
Foundation, and subject to availability of future funding, at least
one additional phase may follow Phase 2. Future phases are expected
to focus on clinical and nonclinical validation of diagnostic tests
that detect active infection by Lyme-disease-causing bacteria, as
well as readiness for regulatory submission and market entry.
Thanks to a $10 million pledge to the LymeX Diagnostics Prize from
the Cohen Foundation, $9 million in additional LymeX prizes are
projected to be available in proposed future phases.
Visit LymeXDiagnosticsPrize.com for more
information and subscribe to the competition newsletter to receive
future updates.
About T2Lyme Panel:The T2Lyme
Panel is a direct-from-blood molecular diagnostic test designed to
run on the FDA-cleared T2Dx® Instrument and to detect Borrelia
burgdorferi, the bacteria that causes Lyme disease. The T2Lyme
Panel is intended to test individuals with signs and symptoms of
Lyme disease and aid in the diagnosis of early Lyme disease. In the
last six months, the T2Lyme Panel received Breakthrough Device
Designation from the U.S. Food and Drug Administration and received
a patent from the U.S. Patent and Trademark Office, both covering
the T2Lyme Panel.
About Lyme Disease:Lyme disease
is a bacterial infection caused by the genes Borrelia and is
transmitted to humans through the bite of infected ticks. It is
considered the most common vector borne illness in the United
States. Borrelia burgdorferi is spread by deer ticks (Ixodes
scapularis) in the northeastern, mid-Atlantic and north-central
regions of the U.S., and by the western blacklegged tick (Ixodes
pacificus) on the Pacific Coast. According to the U.S. Centers for
Disease Control and Prevention (CDC), approximately 476,000
Americans may get Lyme disease each year in the United States.
Typical symptoms include fever, headache, fatigue, and skin rash
called erythema migrans. If left untreated, infection can spread to
joints, the heart, and the nervous system.
About T2 Biosystems:T2 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.
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 our
plan to develop and commercialize a diagnostic test for the
detection of early Lyme disease, the capability of the T2Lyme Panel
to detect early Lyme disease, the market opportunity for a
diagnostic test for early Lyme disease, timing of development of an
LDT for Lyme disease, status of product development pipeline,
product demand, and commitments or opportunities, , 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, 2021, filed with the U.S. Securities and
Exchange Commission, or SEC, on March 23, 2022, 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.
Investor Contact:Philip Trip Taylor, Gilmartin
Groupir@T2Biosystems.com 415-937-5406
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