T2 Biosystems Announces Plan to Commercialize a Diagnostic Test for Early Lyme Disease
October 13 2022 - 9:00AM
T2 Biosystems, Inc. (NASDAQ:TTOO) a leader in the rapid detection
of sepsis-causing pathogens and antibiotic resistance genes,
announced today plans to complete development of, and
commercialize, a diagnostic test for the detection of early Lyme
disease, with the goal of initiating marketing and sales in the
United States as a Laboratory Developed Test (LDT) in 2023.
“We believe there is a significant market
opportunity for a sensitive diagnostic test to detect early Lyme
disease, and initial performance data on the T2Lyme Panel is very
encouraging. Our decision to advance toward commercialization in
2023 follows two recent achievements: the receipt of a patent from
the U.S. Patent and Trademark Office and the receipt of FDA
Breakthrough Device Designation, both covering the T2Lyme Panel,”
stated John Sperzel, Chairman and CEO of T2Biosystems. “While we
plan to commence marketing and sales as an LDT in 2023, we intend
to subsequently initiate a U.S clinical trial for the purpose of
pursuing FDA clearance of the T2Lyme Panel. We believe the T2Lyme
Panel will potentially allow clinicians to ensure patients receive
appropriate therapy faster, and prevent the negative impact of a
delay in delivery of appropriate therapy and the overuse of
antibiotics.”
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.
Laboratory diagnosis of Lyme disease has
traditionally used a two-tier process for detecting the presence of
antibodies against Borrelia burgdorferi in a patient’s blood.
Antibodies are proteins present in the blood when the body is
responding to a specific infection. In the case of Lyme disease,
antibodies can take several weeks to develop, so patients may test
negative using current FDA-cleared diagnostics if a patient has
been recently infected.
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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