T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the
rapid detection of sepsis-causing pathogens and antibiotic
resistance genes, today provided an update on its new product
development pipeline progress. The Company’s product pipeline is
focused on direct-from-blood diagnostic tests for antimicrobial
resistance (AMR), pediatric Candida infections, Lyme disease, and
Candida auris.
Pipeline Progress
Highlights
- Finalizing a 510(k) premarket
notification application for the T2Resistance® Panel planned to be
filed with the U.S. Food and Drug Administration (FDA) during the
fourth quarter of 2024.
- The previously submitted 510(k)
premarket notification to expand use of the T2Candida® Panel to
detect pediatric Candida infections is pending clearance with the
FDA.
- Advanced internal validation and
plans to submit a 510(k) premarket notification to the FDA to
expand the use of its FDA-cleared T2Bacteria® Panel to detect
pediatric bacterial infections.
- The Company maintains its plan to
launch the T2Lyme™ Panel as a Laboratory Developed Test (LDT);
however, it now plans to build or buy its own laboratory rather
than launch through a partnership.
- Pursuing non-dilutive funding to
complete the development, validation, and clinical studies for a
diagnostic test to detect Candida auris, following the completion
of feasibility and early development in collaboration with the U.S.
Centers for Disease Control and Prevention (CDC).
“Our team is making excellent progress
developing novel diagnostics to rapidly detect pathogens
directly-from-blood, including antimicrobial resistance, pediatric
Candida infections, Lyme disease, and Candida auris, and we expect
to launch multiple new products in 2024 and 2025,” stated John
Sperzel, Chairman and CEO of T2 Biosystems. “Three of our
pipeline products have received FDA Breakthrough Device
designation, including the T2Resistance Panel, the T2Lyme Panel,
and the Candida auris test, and we believe all four of our pipeline
products will allow clinicians to achieve faster targeted
treatment, reduce cost, and improve patient outcomes.”
Antimicrobial resistance
According to the CDC, antimicrobial resistance is an urgent global
public health threat. To address the threat caused by AMR, the
Company has developed the T2Resistance Panel, a direct-from-blood
molecular diagnostic test that runs on the FDA-cleared T2Dx®
Instrument and simultaneously detects 13 antibiotic resistance
genes, in just 3-5 hours, without the need to wait days for a
positive blood culture.
In March 2024, the results of a new study were
published in Journal of Clinical Microbiology highlighting the
benefits of the T2Resistance Panel compared to blood culture and
standard microbiology methods, including high accuracy (i.e., 94.7%
sensitivity, 97.4% specificity), rapid turnaround time (i.e.,
results available is 4.4 hours vs. 58.3 hours), and clinical impact
(i.e., clinical interventions in 41% of patients in the study, or
24 of 59 patients).
The Company plans to submit a 510(k) premarket
notification to the FDA during the fourth quarter of 2024 and
expects to receive a prioritized FDA review given the T2Resistance
Panel previously received FDA Breakthrough Device designation.
Pediatric Sepsis According to
the Children’s Hospital Association, sepsis is the leading cause of
death in hospitalized children, more than cancer. To address the
threat of pediatric sepsis, the Company is pursuing pediatric
claims for its T2Candida® Panel and T2Bacteria® Panel, the only
FDA-cleared products able to detect sepsis-causing fungal and
bacterial pathogens direct-from-blood, in just 3-5 hours, without
the need to wait days for a positive blood culture.
According to the Journal of Fungi, a
peer-reviewed scientific journal that provides an advanced forum
for studies related to pathogenic fungi, Candida species are a
major contributor to morbidity and mortality in hospitalized
children. Additionally, children with invasive candidiasis present
a significant burden to the U.S. healthcare system, with a mean
increased hospital length of stay of 21 days and approximately
$92,000 in excess hospital costs. A Journal of Clinical
Microbiology (2022) study conducted at the Bambino Gesù hospital in
Rome, Italy found that pediatric patients suspected of fungal
bloodstream infections that were tested with the T2Candida Panel
received species identification results 121.8 hours faster compared
to blood culture.
The Company previously submitted a 510(k)
premarket notification to the FDA to expand the use of its
FDA-cleared T2Candida Panel to include pediatric testing, and the
indication is pending FDA clearance. The Company also plans to
submit a 510(k) premarket notification to the FDA to expand the use
of its FDA-cleared T2Bacteria Panel to include pediatric
testing.
Lyme DiseaseAccording to the
CDC, Lyme disease is the leading vector-borne disease in the U.S.,
with an estimated 3.4 million tests performed each year at a cost
of nearly $500 million. The current diagnostic process is a
two-tiered antibody test algorithm that relies on the presence of
antibodies, and which is only accurate four to eight weeks after
infection. During those weeks, the bacteria may spread throughout
the body and become much harder to eradicate and treat effectively,
and may lead to chronic, debilitating disease.
To address this critical unmet need, the Company
has developed the T2Lyme Panel, a direct-from-blood molecular
diagnostic test for the early detection of Borrelia burgdorferi,
the bacterium that causes Lyme disease in the United States. Early
detection and appropriate treatment are essential, as untreated
Borrelia burgdorferi infections may spread throughout the body and
lead to chronic, debilitating Lyme disease. The T2Lyme Panel has
been designed to be a highly sensitive detection of an infection
and is expected to detect Lyme disease within the first 30 days
post infection, compared to antibody tests that can take 30-60 days
post infection.
The Company has made an important strategic
decision regarding the commercialization of the T2Lyme Panel. The
Company maintains its plan to launch the T2Lyme Panel as a
Laboratory Developed Test (LDT); however, it now plans to build or
buy its own laboratory rather than to do so through a partnership.
While this is expected to delay the intended launch of the test
beyond the third quarter of 2024, the Company believes this
strategy will be in the best long-term interest of its stockholders
as it is expected to ultimately result in higher profit margins,
give the Company complete control of its Lyme business, and also
provide the potential to use the Lyme laboratory for other tests
developed by the Company.
While the Company plans to launch the T2Lyme
Panel as an LDT, it intends to submit a 510(k) premarket
notification to the FDA and, it will expect to receive a
prioritized FDA review given the T2Lyme Panel previously received
FDA Breakthrough Device designation.
Candida aurisAccording to the
World Health Organization, Candida auris is a multidrug-resistant
pathogen labeled as a growing threat to public health. A 2023 Wall
Street Journal report described Candida auris as a “deadly fungus
spreading across the U.S., mostly in healthcare facilities,” with a
mortality rate of up to 60%. According to the CDC, Candida auris is
difficult to identify with standard laboratory methods, which can
lead to inappropriate treatment, and some strains are resistant to
all three available classes of antifungal therapies.
To address this global threat, the Company
intends to expand its direct-from-blood T2Candida Panel to include
the detection of Candida auris. The FDA-cleared T2Candida Panel
currently covers approximately 90% of Candida species commonly
found in bloodstream infections. The addition of Candida auris
should provide important coverage for infections caused by this
pathogen which are becoming increasingly more prevalent.
T2 Biosystems previously collaborated with the
CDC to complete feasibility and early development of a diagnostic
test to detect Candida auris, and the Company believes it is
possible to receive non-dilutive funding to complete the
development, validation, and clinical studies. The FDA previously
granted the T2 Candida auris test Breakthrough Device designation,
so the Company is having interactive dialog with the FDA and
expects to receive a prioritized review upon submission of a 510(k)
premarket notification to the FDA.
About T2 BiosystemsT2
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 are powered by the proprietary T2 Magnetic
Resonance (T2MR®) technology and include the T2Dx® Instrument, the
T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel,
and the T2Biothreat™ Panel. T2 Biosystems has an active pipeline of
future products, including the U.S. T2Resistance Panel, the T2Lyme™
Panel, and the expended T2Candida Panel to add the detection of
Candida auris. For more information, please visit
www.t2biosystems.com.
Forward-Looking Statements
This 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 the likelihood that the Company
will submit a 510(k) premarket notification for the T2Resistance
Panel to the FDA during the fourth quarter of 2024; the likelihood
that the Company will be successful in receiving approval and
commercializing the T2Resistance Panel, T2Lyme Panel and expanding
the T2Candida Panel for the detection of pediatric sepsis and
Candida auris; the likelihood that the T2Lyme Panel will be able to
detect Borrelia burgdorferi in the first 30 days following
infection; the likelihood that the Company will successful in
building or buying its own laboratory for the testing of the T2Lyme
Panel; the ability for the Company to launch multiple new products
in 2024 and 2025; the likelihood that all four of our pipeline
products will allow clinicians to achieve faster targeted
treatment, reduce cost, and improve patient outcome; the likelihood
that the Company will receive non-diluting funding to complete the
development, validation, and clinical studies for the addition of
Candida auris to the T2Candida Panel, 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.com 415-937-5406
T2 Biosystems (NASDAQ:TTOO)
過去 株価チャート
から 9 2024 まで 10 2024
T2 Biosystems (NASDAQ:TTOO)
過去 株価チャート
から 10 2023 まで 10 2024