T2 Biosystems’ T2Resistance™ Panel is Now Available as a Research Use Only (RUO) Test in the U.S.
September 30 2019 - 7:30AM
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the development
of innovative diagnostic products for critical unmet needs in
healthcare, announced today that its T2ResistanceTM Panel, which
received Breakthrough Device Designation from the Food and Drug
Administration (FDA) earlier this year, is now available as a
research use only (RUO) test in the United States. The T2Resistance
Panel also remains on track to receive CE-Mark for commercial
availability in Europe by the end of 2019.
The T2Resistance Panel RUO identifies 13 of the most serious
resistance genes on the antibiotic-resistance threat list published
by the Centers for Disease Control and Prevention (CDC), including
genes indicating resistance to common empiric antibiotic therapies
such as carbapenems, vancomycin, penicillin and more. It is the
first system that can detect resistance markers directly from whole
blood—in three to five hours.
“With the T2Resistance Panel’s RUO availability, researchers
will be able to demonstrate, understand the value, and the
potential benefits of rapid detection of the genes associated with
antibiotic resistance, including the reduction of unnecessary
antibiotic use, which is a key driver of resistance,” said John
McDonough, chairman and chief executive officer at T2 Biosystems.
“This milestone takes us even closer to bringing this important
technology to market for clinical use, which will have the
potential to further help improve patient outcomes associated with
bloodstream infections and sepsis.”
The panel utilizes the same T2Dx® Instrument as the T2Bacteria®
and T2Candida® Panels – the only FDA-cleared panels that can detect
sepsis-causing pathogens directly from a patient’s blood sample,
without the need to wait for a blood culture. A positive blood
culture takes one to five or more days before subculture and
antimicrobial susceptibility testing (AST) or genomic testing can
commence, which is the current pathway to identifying antibiotic
resistance. Additionally, it can take four blood culture sets to
detect what T2MR® technology can detect in a single blood draw. In
contrast, the T2Bacteria and T2Candida Panels’ sensitivity and
ability to provide results faster are key advantages that enable
positive changes in clinical decisions and outcomes.
“By providing identification and genotypic antibiotic resistance
marker results in only a few hours from a blood sample, clinicians
will be able to more effectively treat their potentially bacteremic
patients at risk of resistant infections, and avoid unnecessary
therapies that further promote antibiotic resistance,” said Dr.
George Pankey, Director of Infectious Disease Research at Ochsner
Clinic Foundation. “The T2Resistance Panel promises to be a
powerful stewardship tool when clinically available, as it will
help ensure that patients are on the most appropriate therapy, and
identify those patients with resistant bloodstream infections
faster than any other diagnostic.”
Recently, T2 Biosystems was awarded a milestone-based contract
of initial value of $6 million with a potential value of up to $69
million, if all contract options are exercised, from the Biomedical
Advanced Research and Development Authority (BARDA), within the
Office of the Assistant Secretary for Preparedness and Response
(ASPR) at the US Department of Health and Human Services’ (HHS).
Additionally, the Company’s T2Bacteria Panel was the first in-vitro
diagnostic test to receive approval for a New Technology Add-on
Payment (NTAP) by the United States Centers for Medicare &
Medicaid Services (CMS).
About T2 Biosystems T2 Biosystems, a
leader in the development and commercialization of innovative
medical diagnostic products for critical unmet needs in healthcare,
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,
T2Candida® Panel, and T2Bacteria® Panel, which was recently
announced as the first and only in-vitro diagnostic test to receive
approval for a New Technology Add-on Payment (NTAP) by CMS, are
powered by the proprietary T2 Magnetic Resonance (T2MR®)
technology. T2 Biosystems has an active pipeline of future
products, including products for the detection of additional
species and antibiotic resistance markers of sepsis pathogens, and
tests for Lyme disease.
Forward-Looking Statements This 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 additional
patients, timing of testing patients, anticipated product benefits,
strategic priorities, product expansion or opportunities, growth
expectations or targets, timing of FDA filings or clearances and
anticipated operating expenses, 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, 2018, filed with the U.S.
Securities and Exchange Commission, or SEC, on March 14, 2019, 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.
Media Contact: Gina Kent, Vault
Communications gkent@vaultcommunications.com
610-455-2763
Investor Contact: Zack Kubow, W2O Group
zkubow@w2ogroup.com 415-658-6436
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