T2 Biosystems Announces FDA 510(k) Submission for the T2Biothreat Panel
23 Maio 2023 - 9:00AM
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens and antibiotic resistance
genes, today announced that it has submitted a 510(k) premarket
notification to the U.S. Food and Drug Administration (FDA) for the
Company’s T2Biothreat™ Panel. The FDA submission follows the
recently completed U.S. clinical evaluation that demonstrated very
high sensitivity and specificity, and included 350 contrived
positive samples and over 470 negative blood samples from both
healthy and febrile subjects.
The T2Biothreat Panel is a fully-automated,
direct-from-blood test designed to run on the FDA-cleared T2Dx®
Instrument and simultaneously detects six biothreat pathogens
identified as threats by the U.S. Centers for Disease Control and
Prevention, including the organisms that cause anthrax (Bacillus
anthracis), tularemia (Francisella tularensis), glanders
(Burkholderia mallei), melioidosis (Burkholderia pseudomallei),
plague (Yersinia pestis), and typhus (Rickettsia prowazekii). Rapid
detection of these pathogens is essential to getting infected
patients on the appropriate antimicrobial therapy and improving
clinical outcomes.
"This FDA submission marks an important
milestone in our commitment to protect Americans from the threat of
deliberate or naturally occurring outbreaks of biothreat
pathogens,” stated John Sperzel, Chairman and CEO of T2 Biosystems.
“We believe the T2Biothreat Panel demonstrates very high
sensitivity and specificity for a direct-from-blood multi-target
biothreat product, the only such product developed by a U.S.-owned
company, and we look forward to working through the FDA premarket
review process to obtain clearance.”
In a public health emergency involving biothreat
pathogens, rapid and accurate diagnostic testing is expected to
play a central role in minimizing health and economic impact. If
not treated promptly, infections with these pathogens can result in
mortality rates of 40-90%, as described in Medical Aspects of
Biological Warfare and by the Center for Food Security and Public
Health. The T2Biothreat Panel is able to detect the aforementioned
biothreat pathogens within 4 hours and provide clinicians with the
needed information to appropriately treat infected patients.
This project has been funded in whole or in part
with federal funds from the U.S. Department of Health and Human
Services, Administration for Strategic Preparedness and Response,
Biomedical Advanced Research and Development Authority (BARDA),
under contract number 75A50119C00053.
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 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. For more information, please
visit www.t2biosystems.com.
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 the
ability of the T2Biothreat Panel to simultaneously detect six
biothreat pathogens, product demand, and the ability of the
T2Biothreat Panel to protect Americans from the threat of
deliberate or naturally occurring outbreaks of biothreat pathogens,
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, 2022, filed
with the U.S. Securities and Exchange Commission, or SEC, on March
31, 2023, 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)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
T2 Biosystems (NASDAQ:TTOO)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024