T2 Biosystems Receives FDA 510(k) Clearance for the T2Biothreat Panel
19 Setembro 2023 - 10:00AM
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens and antibiotic resistance
genes, today announced that it has received 510(k) clearance from
the U.S. Food and Drug Administration (FDA) for the T2Biothreat™
Panel. The FDA 510(k) clearance allows the company to immediately
begin marketing and selling the T2Biothreat Panel in the U.S.
market.
The T2Biothreat Panel is a direct-from-blood
molecular diagnostic test that runs on the FDA-cleared T2Dx®
Instrument and simultaneously detects six biothreat pathogens,
including the organisms that cause anthrax (Bacillus anthracis),
tularemia (Francisella tularensis), glanders (Burkholderia mallei),
melioidosis (Burkholderia pseudomallei), plague (Yersinia pestis),
and typhus (Rickettsia prowazekii). These pathogens have been
identified as threats by the U.S. Centers for Disease Control and
Prevention and identified as material biological threats under
section 319-2(c)(2)(A)(ii) of the Public Health Service Act.
The T2Biothreat Panel is the first and only
FDA-cleared product able to simultaneously detect these six
high-priority biothreat pathogens, and the only FDA-cleared
multi-target biothreat product developed and manufactured by a U.S.
owned company. The U.S. clinical evaluation to support the FDA
510(k) submission included testing of the T2Biothreat Panel at
MRIGlobal, a Biosafety Level 3 laboratory specializing in biothreat
pathogens, and Ochsner Medical Center. The clinical evaluation
assessed the sensitivity and specificity of the panel to detect
targets in blood samples containing a range of bacterial
concentrations. The positive percent agreement for all targets at
1-3 times the limit of detection was 100% for all targets except F.
tularensis, which was 94.3%. The negative percent agreement for all
six targets in healthy or febrile blood containing no bacteria was
100%.
"The FDA 510(k) clearance for the T2Biothreat
Panel marks a major milestone in our collaboration with the U.S.
Government, specifically Biomedical Advanced Research and
Development Authority (BARDA), and our commitment to protect
Americans from the consequences of deliberate or naturally
occurring outbreaks of these biothreat pathogens,” stated John
Sperzel, Chairman and CEO at T2 Biosystems. “With receipt of the
FDA 510(k) clearance, which we believe demonstrates unparalleled
sensitivity and specificity in direct-from-blood multi-target
biothreat detection, we have immediately shifted our focus to
commercialization of the T2Biothreat Panel, which we intend to sell
to commercial markets and governments.”
If not treated promptly, infections with the
pathogens included on the T2Biothreat Panel can result in mortality
rates of 40-90%, according to Medical Aspects of Biological Warfare
and The Center for Food Security and Public Health. In the event of
a public health emergency involving biothreat pathogens, rapid and
accurate diagnostic testing is expected to play a central role in
achieving targeted antimicrobial treatment, improving patient
outcomes, and minimizing economic impact. The T2Biothreat Panel is
able to detect the six aforementioned biothreat pathogens within
four hours providing clinicians with the needed information to
appropriately treat infected patients.
The six biothreat pathogens detected by the
T2Biothreat Panel are identified as biological threats by the U.S.
Administration for Strategic Preparedness and Response (ASPR).1
ASPR engages partners through Public Health Emergency Medical
Countermeasures Enterprise (PHEMCE) activities to share information
and coordinate plans and actions to ensure the nation has and can
use medical countermeasures to protect Americans during disasters
and emergencies resulting from known and unknown chemical,
biological, radiological, or nuclear (CBRN) threats and emerging
infectious diseases.
This project has been funded in whole or in part
with federal funds from the U.S. Department of Health and Human
Services (HHS), Administration for Strategic Preparedness and
Response (ASPR), Biomedical Advanced Research and Development
Authority (BARDA), under contract number
75A50119C00053.
1.
https://aspr.hhs.gov/PHEMCE/Pages/Threats.aspx
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, the
T2Biothreat™ 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
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, the ability of the T2Biothreat
Panel to protect Americans from the threat of deliberate or
naturally occurring outbreaks of biothreat pathogens, and our
ability to sell the T2Biothreat Panel to commercial markets and
Governments, 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
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