T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the development and
commercialization of innovative medical diagnostic products for
critical unmet needs in healthcare, and CARB-X, a global non-profit
partnership dedicated to accelerating early development
antibacterial R&D to address the rising global threat of
drug-resistant bacteria, announced today that the
T2Resistance
™ Panel is the first diagnostic to
graduate from CARB-X’s portfolio. The graduation marks an important
milestone on the path toward approval for use on patients in
hospitals in the U.S., Europe and elsewhere around the globe.
In 2017, CARB-X awarded T2 Biosystems $2.0 million to support
the development of the T2Resistance Panel, designed to detect 13
resistance genes from both gram-positive and gram-negative
pathogens directly from a whole-blood specimen, without the need to
wait for blood cultures. The panel was granted Breakthrough Device
designation by the Food and Drug Administration (FDA) earlier this
year and is expected to be available for research use only (RUO) in
the US by the end of Q3 2019 and receive CE-Mark for commercial
availability in Europe by the end of 2019.
“Addressing the global superbug crisis requires urgent
development of innovative diagnostics, like T2’s technology, as
well as new drugs and vaccines. This is the first diagnostic to
graduate from CARB-X’s portfolio, and we are excited that we could
help T2 with funding and support to develop this technology,” said
Kevin Outterson, Executive Director of CARB-X, which is based at
the Boston University School of Law. “The T2Resistance Panel will
provide healthcare professionals with a new rapid test, a first of
its kind, to provide timely and accurate detection of
drug-resistant infections and inform treatment decisions to ensure
patients are given the most appropriate care.”
“We are incredibly grateful to CARB-X for the funding and
support they provided to our team in the development of the
T2Resistance Panel over the past year and a half,” said John
McDonough, chairman and chief executive officer of T2 Biosystems.
“Rapid identification of the genes and species associated with
antibiotic resistance can help enable the reduction of unnecessary
antibiotic use, which is the primary cause of resistance. Being the
first diagnostic to graduate from CARB-X’s portfolio is a
significant milestone in the development of technology that has
such capabilities.”
The T2Resistance Panel identifies 13 of the most serious
superbugs and 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.
Diagnosing infections faster means saving lives and
fighting the spread of superbugs
Bacterial bloodstream infections can be deadly even at low
concentrations. If bacterial infections are identified quickly,
patients can be placed on effective antibiotic therapy faster. T2MR
technology enables rapid identification of bacterial pathogens and
resistance markers directly in whole blood within three to five
hours. Existing diagnostics rely primarily on blood cultures
conducted in laboratories, which can take days, and do not always
produce reliable results. As a result, physicians are often unable
to treat infections quickly with the appropriate antibiotics,
leading to higher mortality and use of unnecessary antibiotics.
T2 Biosystems is the company behind the T2Bacteria Panel, which
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). The panel is the only
FDA-cleared test to identify sepsis-causing bacterial pathogens
directly from whole blood without the need to wait for blood
culture, and its counterpart for fungal bloodstream infections is
the T2Candida Panel, the first and only FDA-cleared
direct-from-whole blood diagnostic for detection of fungal
pathogens that are associated with sepsis. Both panels provide
results in three to five hours instead of days. The products are
two of several panels that are approved or in development that are
run on the Company’s T2Dx® Instrument, which is powered by
miniaturized magnetic resonance (T2MR®) technology.
The CARB-X graduation news follows the recent announcement that
T2 Biosystems has been 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).
BARDA is also the main US founder and funder of CARB-X.
Supporting innovation in the race against drug-resistant
bacteria
Drug-resistant infections are responsible for an estimated
700,000 deaths worldwide each year, according to the World Health
Organization (WHO).
The CARB-X portfolio is the world’s largest early development
portfolio addressing drug-resistant bacteria, with 31 active
projects. In the three years since its launch, CARB-X has funded
and supported 48 innovative projects, for a total obligation of
over $139.4 million with the potential of additional funds if
project milestones are met. These funds are in addition to
investments made by the companies themselves. The CARB-X pipeline
will continuously evolve, as projects progress and graduate from
CARB-X and others fail for a variety of reasons. The current
portfolio supports 13 new classes of antibiotics, 15 new molecular
targets, 12 non-traditional approaches including microbiome-based
therapeutics, four diagnostics and three vaccines.
CARB-X is investing up to $500 million in antibacterial R&D
between 2016-2021. The goal is to support projects in the early
phases of development, so that they will attract additional private
or public support for further clinical development and approval for
use in patients. CARB-X funding is restricted to projects that
target drug-resistant bacteria highlighted on the CDC’s 2013
Antibiotic Resistant Threats list, or the Priority Bacterial
Pathogens list published by the WHO in 2017.
CARB-X is led by Boston University and funding is provided by
BARDA, the Wellcome Trust, Germany’s Federal Ministry of
Education and Research (BMBF), the UK Department of Health and
Social Care’s Global Antimicrobial Resistance Innovation Fund (UK
GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind
support from National Institute of Allergy and Infectious
Diseases (NIAID).
This news release is supported by the
Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and
awards from Wellcome Trust, the German Federal
Ministry of Education and Research, as administrated by CARB-X. The
content is solely the responsibility of the authors and
does not necessarily represent the official views of the
Department of Health and Human Services Office of the Assistant
Secretary for Preparedness and Response, other funders, or
CARB-X.
Media Contacts:
CARB-X:Jennifer
Robinsoncarbxpr@bu.edu+1-514-914-8974
T2 Biosystems: Gina Kent, Vault
Communicationsgkent@vaultcommunications.com +1-610-455-2763
T2 Biosystems Investor Contact: Zack
Kubow, W2O Groupzkubow@w2ogroup.com +1-415-658-6436
About CARB-X CARB-X is a global non-profit
partnership dedicated to accelerating early development
antibacterial R&D to address the rising global threat of
drug-resistant bacteria. CARB-X is led by Boston University
and funding is provided by the Biomedical Advanced Research
and Development Authority (BARDA), part of the Office of the
Assistant Secretary for Preparedness and Response (ASPR) in the US
Department of Health and Human Services , the Wellcome
Trust, a global charity based in the UK working to improve
health globally, Germany’s Federal Ministry of Education and
Research (BMBF), the UK Department of Health and Social Care’s
Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill
& Melinda Gates Foundation, and with in-kind support
from National Institute of Allergy and Infectious
Diseases (NIAID), part of the US National Institutes of Health
(NIH). A non-profit partnership, CARB-X is investing up to
$500 million from 2016-2021 to support innovative antibiotics and
other therapeutics, vaccines, and rapid diagnostics. CARB-X
supports the world’s largest and most innovative pipeline of
preclinical products against drug-resistant infections. CARB-X is
headquartered at Boston University School of Law.
https://carb-x.org/. Follow us on Twitter @CARB_X.
About T2 BiosystemsT2 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.
About BARDA and NIAIDThe US Department of
Health and Human Services works to enhance and protect the health
and well-being of all Americans, providing for effective health and
human services and fostering advances in medicine, public health,
and social services. Within HHS, ASPR’s mission is to save lives
and protect Americans from 21st century health security threats.
ASPR leads the nation’s medical and public health preparedness for,
response to, and recovery from disasters and public health
emergencies. BARDA provides a comprehensive, integrated, portfolio
approach to the advanced research and development, innovation,
acquisition, and manufacturing of medical countermeasures –
vaccines, drugs, therapeutics, diagnostic tools, and
non-pharmaceutical products for public health emergency threats.
These threats include chemical, biological, radiological, and
nuclear agents, pandemic influenza, and emerging infectious
diseases. NIH is the primary US federal agency conducting and
supporting basic, clinical, and translational medical research, and
is investigating the causes, treatments, and cures for both common
and rare diseases. NIAID conducts and supports research — at NIH,
throughout the United States, and worldwide — to study the causes
of infectious and immune-mediated diseases, and to develop better
means of preventing, diagnosing and treating these illnesses.
About Wellcome Trust Wellcome exists to improve
health for everyone by helping great ideas to thrive. We're a
global charitable foundation, both politically and financially
independent. We support scientists and researchers, take on big
problems, fuel imaginations and spark debate. The Wellcome Trust is
a charity registered in England and Wales, no. 210183. Its sole
trustee is The Wellcome Trust Limited, a company registered in
England and Wales, no. 2711000 (whose registered office is at 215
Euston Road, London NW1 2BE, UK)
About BMBFEducation and research are the
foundations for our future. The promotion of education, science and
research by the Federal Ministry of Education and Research (BMBF)
represents an important contribution to securing Germany's
prosperity. Education and research are a Federal Government policy
priority, which is reflected in the development of the funding it
is making available to these fields.
About the Global AMR Innovation Fund
(GAMRIF)The Department for Health and Social Care (DHSC)
is the UK Government department which is responsible for helping
people to live more independent, healthier lives for longer.
The partnership with CARB-X is part of DHSC’s Global
Antimicrobial Resistance Innovation Fund (GAMRIF). GAMRIF was
established to provide seed funding for innovative research and
development, specifically in neglected and underinvested areas, in
the field of AMR. GAMRIF is a £50m UK Aid investment, which means
all projects funded must support research primarily and directly
for the benefit of people in low- and middle-income countries
(LMICs). The Fund takes a ‘One Health’ approach, seeking to invest
in potential solutions to reduce the threat of AMR in humans,
animals, fish and the environment. The Fund seeks to leverage
additional global funding through interaction with international
government bodies, public-private partnerships, product development
partnerships, global funding mechanisms and global fora.
About Boston University Founded in 1839,
Boston University is an internationally recognized institution of
higher education and research. With more than 33,000 students,
it is the fourth-largest independent university in the United
States. BU consists of 17 schools and colleges, along with a number
of multi-disciplinary centers and institutes integral to the
University’s research and teaching mission. In 2012, BU
joined the Association of American Universities (AAU), a
consortium of 62 leading research universities in the United States
and Canada. For further information, please contact Jeremy Thompson
at jeremy22@bu.edu. www.bu.edu.
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