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).