T2 Biosystems Receives FDA Clearance to Market the T2Candida Panel for Pediatric Patients
2024年9月16日 - 10:00PM
T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the
rapid detection of sepsis-causing pathogens and antibiotic
resistance genes, today announced that it has received clearance
from the U.S. Food and Drug Administration (FDA) to market its
FDA-cleared T2Candida® Panel for pediatric patients. The Company
expects to immediately begin marketing and selling the T2Candida
Panel under the expanded pediatric claim.
The T2Candida Panel is the only FDA-cleared
diagnostic test able to detect sepsis-causing Candida species
directly-from-blood, in just 3-5 hours, without the need to wait
days for a positive blood culture. The T2Candida
Panel runs on the FDA-cleared T2Dx® Instrument and
simultaneously detects five Candida species including, Candida
albicans, Candida tropicalis, Candida
parapsilosis, Candida krusei, and Candida glabrata. According
to the U.S. Centers for Disease Control and Prevention (CDC), the
five species detected by the T2Candida Panel account for up to 95%
of all Candida bloodstream infections in the U.S.
"This FDA clearance marks another important
milestone in our commitment to expand the clinical utility of our
sepsis test panels and allows our commercial team to immediately
begin marketing and selling our test to over 200 children’s
hospitals in the U.S.,” stated John Sperzel, Chairman and CEO of T2
Biosystems. “Studies show that the T2Candida Panel detects Candida
species significantly faster, and with greater sensitivity, when
compared to blood culture-based diagnostics, and we believe the new
pediatric testing claim will allow clinicians to improve outcomes
and reduce cost by achieving faster targeted antifungal treatment
for their pediatric patients.”
According to the Journal of Fungi, a
peer-reviewed scientific journal that provides an advanced forum
for studies related to pathogenic fungi, Candida species are a
major contributor to morbidity and mortality in hospitalized
children. Moreover, children with invasive candidiasis present a
significant burden to the U.S. healthcare system, with a mean
increased hospital length of stay of 21 days and approximately
$92,000 in excess hospital costs.
A Journal of Clinical Microbiology (2022) study
conducted at the Bambino Gesù hospital in Rome, Italy found that
pediatric patients suspected of fungal bloodstream infections that
were tested with the T2Candida Panel received species
identification results 121.8 hours faster compared to blood
culture. The study also found a higher detection rate with the
T2Candida Panel, as six additional probable or possible fungal
bloodstream infections in pediatric patients were detected by the
T2Candida Panel that were missed by blood culture. In addition, a
prospective observational study published in Clinical Infectious
Diseases (2022) evaluated the performance of four pre-blood culture
tests for detecting the presence of invasive candidiasis in
pediatric patients and found that the T2Candida Panel had the
highest sensitivity and specificity of all four assays among five
hundred patients enrolled. The T2Candida Panel was the only test
recommended for individual use as a tool for the diagnosis of
invasive candidiasis in at-risk children and adolescents.
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 are powered by the proprietary T2 Magnetic
Resonance (T2MR®) technology and include the T2Dx® Instrument, the
T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel,
and the T2Biothreat™ Panel. T2 Biosystems has an active pipeline of
future products, including the U.S. T2Resistance Panel, the T2Lyme™
Panel, and the expended T2Candida Panel to add the detection of
Candida auris. 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 T2Candida Panel to detect Candida species in pediatric
patients; the ability of the T2Candida Panel to detect Candida
species in pediatric patients significantly faster and with greater
sensitivity than blood culture; and the likelihood that the
expansion of the T2Candida pediatric testing claim will allow
clinicians to improve outcomes and reduce cost by achieving faster
targeted antifungal treatment for their pediatric patients, 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, 2023, filed with the U.S. Securities and
Exchange Commission, or SEC, on April 1, 2024, 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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