T2 Biosystems Announces Letter of Intent to Enter Strategic Partnership for Lyme Disease
07 5월 2024 - 10:00PM
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens and antibiotic resistance
genes, today announced that it has signed a non-binding letter of
intent (“LOI”) to enter into a strategic partnership with ECO
Laboratory, a Massachusetts-based clinical laboratory certified
under the Clinical Laboratory Improvement Amendments (CLIA).
ECO Laboratory was founded by Karen Weeks, who
has been at the forefront of Lyme disease research and testing for
decades. She is co-author of extensive publications pertaining to
tick-borne diseases, including The New England Journal of Medicine
and The Journal of Infectious Diseases. While supervising the
Virology Department at the Massachusetts Department of Public
Health, and working directly with Allen Steere, MD at Tufts
University Medical Center, Ms. Weeks developed the Lyme Antibody
Capture Immunoassay, which remains one of the most sensitive
serology tests available for Lyme disease. In 1990, Ms. Weeks
co-founded IMUGEN, Inc., the premier laboratory for the diagnosis
of Lyme disease and many other tick-borne diseases, which was
acquired by Oxford Immunotec in 2016.
"We look forward to entering into a strategic
partnership with ECO Laboratory and its founder Karen Weeks, who
has significant experience and expertise in the Lyme diagnostic
market,” stated John Sperzel, Chairman and CEO of T2 Biosystems.
“Together, we plan to launch the T2Lyme Panel as a Laboratory
Developed Test (LDT), for the detection or early Lyme disease, and
build the premier Lyme testing laboratory in the United
States.”
The T2Lyme Panel is a direct-from-blood
molecular diagnostic test designed for the early detection of
Borrelia burgdorferi, the bacterium that causes Lyme disease in the
United States. Lyme disease is the leading vector-borne disease in
America, with an estimated 3.4 million tests performed each
year.
The current diagnostic process is a two-tiered
antibody test algorithm that relies on the presence of antibodies
and can only be used accurately four to eight weeks after
infection. If left untreated, the bacteria may spread throughout
the body and become much harder to eradicate and treat effectively.
Although early symptoms of Lyme disease are similar to the flu,
Borrelia burgdorferi infections can lead to chronic, debilitating
disease. To address this critical unmet need, we have developed a
highly sensitive diagnostic test for the detection of early Lyme
disease, with an analytical sensitivity that is in line with our
FDA-cleared sepsis tests. We believe our test will detect Lyme
disease within the first 30 days after infection, compared to
antibody tests that can take 30-60 days after infection. We are
finalizing internal validation and verification, and we expect to
be in position for a product launch during the third quarter of
2024.
The Company expects to announce details
regarding the strategic partnership with ECO Laborator when
the definitive agreement has been executed.
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 T2Biothreat™ Panel, and are powered by the proprietary T2
Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active
pipeline of future products, including the U.S. T2Resistance Panel,
the Candida auris test, and the T2Lyme™ Panel.
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 about the
Company’s ability to regain compliance with the listing
requirements of the Nasdaq Capital market, as well as statements
that include the words “expect,” “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, 2023, filed with the U.S. Securities and
Exchange Commission, or SEC, on April 1, 2024, and other filings
the Company makes with the SEC from time to time, including our
Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
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.com415-937-5406
T2 Biosystems, Inc. has filed a
registration statement for a Form S-1 (including a preliminary
prospectus) with the Securities and Exchange Commission, or the
SEC, for the public offering. Before you invest, you should read
the Preliminary Prospectus and the other documents T2 Biosystems,
Inc. has filed with the SEC for more complete information about T2
Biosystems, Inc. and the public offering. You may get these
documents for free by visiting EDGAR on the SEC web site at
www.sec.gov. Alternatively, T2 BioSystems, Inc., A.G.P. or any
dealer participating in the public offering will arrange to send
you the Preliminary Prospectus if you request it by contacting
A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor,
New York, NY 10022, or by telephone at (212) 624-2060.
T2 Biosystems (NASDAQ:TTOO)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
T2 Biosystems (NASDAQ:TTOO)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024