T2 Biosystems Receives FDA Breakthrough Device Designation for Candida Auris Diagnostic Test
20 Julho 2023 - 9:30AM
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens and antibiotic resistance
genes, announced today the U.S. Food and Drug Administration (FDA)
has granted Breakthrough Device designation for the Company’s
Candida auris (C. auris) direct-from-blood molecular diagnostic
test.
This marks the third T2 Biosystems’ product to
receive FDA Breakthrough Device designation, as the Company was
previously granted FDA Breakthrough Device designation for its
T2Resistance® Panel and T2Lyme™ Panel. The Company plans to expand
the test menu on its FDA-cleared T2Dx® Instrument by adding the C.
auris diagnostic test that is designed to detect C. auris species
directly from blood in just 3-5 hours, without the need to wait
days for a positive blood culture.
"We are pleased with the FDA’s decision to grant
Breakthrough Device designation for our Candida auris test, which
provides greater and more frequent access to the FDA and may
accelerate our path to FDA clearance,” stated John Sperzel,
Chairman and CEO of T2 Biosystems. “We believe adding Candida
auris to the test menu on our FDA-cleared T2Dx Instrument will
provide clinicians with a valuable tool to rapidly detect a
dangerous, multidrug-resistant fungal pathogen much faster than
blood culture-based methods, strengthening our value proposition
and increasing the attractiveness of our products to U.S.
hospitals.”
Candida auris is a multidrug-resistant fungal
pathogen recognized as a serious global health threat with a
mortality rate of up to 60%, and is difficult to identify with
standard laboratory methods, which can lead to inappropriate
treatment. The CDC estimates the costs associated with U.S. fungal
diseases, in general, are as high as $48 billion annually, and has
called on public health professionals to help lower the burden of
fungal disease by continuing to raise awareness of the life-saving
benefits of early detection and proper treatment.
The Company currently markets and sells the
T2Candida® Panel, the only FDA-cleared diagnostic test able to
detect sepsis-causing fungal pathogens directly from blood, without
the need to wait days for a positive blood culture. The
T2Candida Panel runs on the fully-automated T2Dx Instrument
and simultaneously detects five Candida species,
including Candida albicans, Candida
tropicalis, Candida parapsilosis, Candida krusei,
and Candida glabrata. Rapid detection of these pathogens, as
well as Candida auris, is essential to getting infected
patients on appropriate antifungal therapy and improving clinical
outcomes.
About FDA Breakthrough Devices
Program The FDA Breakthrough Devices Program is a
voluntary program for certain medical devices and device-led
combination products that provide for more effective treatment or
diagnosis of life-threatening or irreversibly debilitating diseases
or conditions. It is available for devices and device-led
combination products which are subject to review under a premarket
approval application (PMA), premarket notification (510(k)), or De
Novo classification request (De Novo request). This program is
intended to help patients have more timely access to these medical
devices by expediting their development, assessment, and review,
while preserving the statutory standards for PMA approval, 510(k)
clearance, and De Novo marketing authorization, consistent with the
FDA’s mission to protect and promote public health. For more
information, please visit:
https://www.fda.gov/media/108135/download.
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 Candida
auris test, 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
potential that the Breakthrough Device designation will accelerate
the FDA clearance of the Candida auris test or the Company’s
commercialization of the Candida auris test, the ability of the
Candida auris test to successfully detect Candida auris, 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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