T2 Biosystems Announces FDA 510(k) Submission to Expand the Pathogen Detection on its FDA-Cleared T2Bacteria Panel to Include Detection of Acinetobacter baumannii
2023年10月13日 - 5:02AM
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) to
expand the number of pathogens detected on the FDA-cleared
T2Bacteria® Panel to include the detection of Acinetobacter
baumannii (A. baumannii).
A. baumannii is a cause of bloodstream
infections especially in critically ill patients, which can range
from a benign transient bacteremia to septic shock. In a large
study of nosocomial bloodstream infections, A. baumannii was the
tenth most common pathogen and has a crude ICU mortality rate of
34.0% to 43.4%. A. baumannii infections typically occur in
people in healthcare settings and pose risk to those who are on
ventilators, have devices such as catheters, have open wounds from
surgery, are in intensive care units, or have prolonged hospital
stays.
“We are excited about the potential to expand
the number of pathogens detected by our FDA-cleared T2Bacteria
Panel to include the detection of A. baumannii,” stated John
Sperzel, Chairman and CEO of T2 Biosystems. “We believe the
addition of A. baumannii will lead to increased adoption as it
increases the detection capabilities of our FDA-cleared T2Bacteria
Panel to approximately 75% of all sepsis-causing bacterial
pathogens commonly found in blood stream infections.”
Due to the emergence of pan-antibiotic resistant
A. baumannii, the World Health Organization has identified A.
baumannii as the most critically important bacteria that requires
improved prevention and therapeutic approaches. There are few
antimicrobial options for carbapenem resistant A. baumannii, which
can increase mortality rates to 70%. Acinetobacter resistance to
many antibiotics, including carbapenems, highlights the importance
of rapid detection and targeted antimicrobial treatment.
The T2Bacteria Panel is the first and
only FDA-cleared product able to detect sepsis-causing
pathogens directly in whole blood, in 3 to 5 hours, without the
need to wait days for a positive blood culture. The FDA-cleared
T2Bacteria Panel currently detects E. faecium, S. aureus, K.
pneumoniae, P. aeruginosa, and E. coli, and the CE marked
version detects the aforementioned pathogens plus A. baumannii.
Rapid detection of these pathogens is essential to getting infected
patients on the appropriate antimicrobial therapy and improving
clinical outcomes.
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
expanded T2Bacteria Panel to add Acinetobacter baumannii, the
Candida auris test, and the 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 our
ability to expand the number of pathogens detected by our
FDA-cleared T2Bacteria Panel to include the detection of A.
baumannii, including our ability to increase the detection
capabilities of our FDA-cleared T2Bacteria Panel to approximately
75% of all sepsis-causing bacterial pathogens commonly found in
blood stream infections, 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)
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T2 Biosystems (NASDAQ:TTOO)
過去 株価チャート
から 5 2023 まで 5 2024