T2 Biosystems Initiates Studies to Add Acinetobacter Baumannii to the FDA-Cleared T2Bacteria Panel
October 20 2022 - 9:05AM
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens and antibiotic resistance
genes, announced today that it has initiated studies to expand the
number of pathogens detected on the FDA-cleared T2Bacteria® Panel
to include the detection of Acinetobacter baumannii.
A. baumannii is a cause of bloodstream
infections especially in critically ill patients, which can range
from a benign transient bacteremia to fulminant septic shock. 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. 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%.
“We are excited about the potential to expand
the number of pathogens detected by our FDA-cleared T2Bacteria
Panel. In the U.S., Acinetobacter infections rarely occur outside
of healthcare settings and can disproportionally impact those with
weakened immune systems, chronic lung disease, or diabetes,” stated
John Sperzel, Chairman and CEO of T2 Biosystems. “Acinetobacter can
be resistant to many antibiotics, including carbapenems, which
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.
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, T2Bacteria®
Panel, T2Candida® Panel, T2Resistance® Panel, and T2SARS-CoV-2™
Panel and are powered by the Company’s proprietary T2 Magnetic
Resonance (T2MR®) technology. T2 Biosystems has an active pipeline
of future products, including the T2Biothreat Panel, T2Cauris™
Panel, T2Lyme™ Panel, as well as additional 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 T2 Biosystems’ to expand the number of pathogens
detected on the T2Bacteria Panel, the benefits of T2 Biosystems’
technology, or the impact that rapid detection of pathogens can
have on the lives of patients, as well as statements that include
the words “expect,” “intend,” “plan”, “believe”, “project”,
“forecast”, “estimate,” “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, 2021, filed with the U.S. Securities and
Exchange Commission, or SEC, on March 23, 2022, and other filings
the company makes with the SEC from time to time. 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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