T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens, today announced that it has
entered into a worldwide licensing agreement for a rapid COVID-19,
novel coronavirus test developed by the Center of Discovery and
Innovation at Hackensack Meridian Health, New Jersey’s largest and
most comprehensive health network.
The licensed coronavirus assay has been used by
healthcare professionals within the Hackensack Meridian Health
network, under the U.S. Food and Drug Administration’s Emergency
Use Authorization guidance, to test and treat patients suspected of
having coronavirus. Under terms of the agreement, T2 Biosystems
will adapt the coronavirus test to run on its T2Dx® Instrument, the
same instrument used for the FDA-cleared T2Bacteria® and T2Candida®
Panels. Hackensack Meridian Health will also adopt the T2Dx®
Instrument and test panels within its Center of Discovery and
Innovation.
“This agreement combines our FDA-cleared T2Dx
platform with our joint scientific expertise to benefit patients at
risk for both primary coronavirus infections, as well as associated
secondary infections that may lead to sepsis,” said John Sperzel,
President and Chief Executive Officer of T2 Biosystems. “Data from
prior flu pandemics indicated bacterial co-infection rates as high
as 29%, and sepsis rates above 30% among patients admitted to
hospital intensive care units. The ability to detect coronavirus
and associated secondary bacterial or fungal infections that may
lead to sepsis, without the need to wait days for a diagnostic
result, allows clinicians to achieve targeted therapy faster, and
can lead to reduced length of stay in the intensive care unit,
freeing up beds for incoming patients.”
By adding this complementary test to the T2Dx
platform, capable of detecting SARS-CoV-2 (novel coronavirus), T2
Biosystems will be able to provide a comprehensive assessment of
patients suspected of primary or secondary infections associated
with coronavirus, when timely results are most critical. These
results will enable clinicians to rapidly quarantine and treat
patients suspected of having coronavirus, effectively allocate
critical resources, and in the case of a negative result, spare the
patient unnecessary time in the hospital, thus reducing risks to
additional exposure.
“Our scientists at the Center for Discovery and
Innovation have given our health network a crucial tool to treat
patients in real-time,” said Robert C. Garrett, FACHE, Chief
Executive Officer of Hackensack Meridian Health. “We are pleased to
license the technology to T2 Biosystems and also adopt the T2Dx
platform.”
The ongoing pandemic has accelerated the need
for worldwide testing. The World Health Organization (WHO) has
confirmed nearly 335,000 cases globally and the most recent reports
indicate a death toll of more than 14,500. In the United States,
more than 33,400 cases have been reported across all 50 states,
with 400 deaths, according to the Centers for Disease Control and
Prevention (CDC).
“We developed a highly sensitive and accurate
coronavirus test that provides rapid, definitive results by
combining the best elements found in the coronavirus tests
developed by CDC and WHO,” said David S. Perlin, Ph.D., Chief
Scientific Officer and Senior Vice President of the CDI. “The T2Dx®
Instrument is the perfect vehicle to expand our innovation to
customers around worldwide.”
While the majority of confirmed cases have been
mild to moderate in severity, nearly 14% of patients have suffered
from severe disease, exhibiting signs and symptoms that also meet
SIRS criteria, putting those patients at high risk for
sepsis. Additionally, 6.1% of patients were found to be
critical, suffering from respiratory failure, septic shock, and/or
multiple organ dysfunction/failure. These patients are treated in
the ICU, where they are exposed to additional risk factors as well
as countless antimicrobial agents.
About T2 BiosystemsT2
Biosystems, a leader in the rapid detection of sepsis-causing
pathogens, 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, the T2Bacteria® Panel, and the
T2ResistanceTM Panel and 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.
About Hackensack Meridian
Health Hackensack Meridian Health is a leading
not-for-profit health care organization that is the largest, most
comprehensive and truly integrated health care network in New
Jersey, offering a complete range of medical services, innovative
research and life-enhancing care. Hackensack Meridian Health
comprises 17 hospitals from Bergen to Ocean counties, a behavioral
health hospital, and two rehabilitation hospitals. Additionally,
the network has more than 500 patient care locations throughout the
state which include ambulatory care centers, surgery centers, home
health services, long-term care and assisted living communities,
ambulance services, lifesaving air medical transportation, fitness
and wellness centers, rehabilitation centers, urgent care centers
and physician practice locations. Hackensack Meridian Health has
more than 34,100 team members, and 6,500 physicians and is a
distinguished leader in health care philanthropy, committed to the
health and well-being of the communities it serves. For additional
information, please visit
www.HackensackMeridianHealth.org.
About the Center for Discovery and
InnovationThe Center for Discovery and Innovation, a newly
established member of Hackensack Meridian Health, seeks to
translate current innovations in science to improve clinical
outcomes for patients with cancer, infectious diseases and other
life-threatening and disabling conditions. The CDI, housed in a
fully renovated state-of-the-art facility, offers world-class
researchers a support infrastructure and culture of discovery that
promotes science innovation and rapid translation to the
clinic.
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, 2019, filed with the U.S.
Securities and Exchange Commission, or SEC, on March 16, 2020, 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
610-455-2763Investor Contact: Philip Trip Taylor,
Gilmartin Group philip@gilmartinIR.com 415-937-5406
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