Day Zero’s diagnostic is the 60th project funded by CARB-X since 2016
New diagnostic system combines whole-genome sequencing and machine learning to identify a pathogen and its drug-resistance profile within hours, not days
(BOSTON: May 11, 2020) – CARB-X is awarding Day Zero Diagnostics, based in Boston, up to US$6.2 million in non-dilutive funding to develop a diagnostic system that could diagnose bacterial infections more quickly – within hours rather than days – and show physicians which antibiotics are most likely to effectively treat the infection. The innovative technology combines whole-genome sequencing and machine learning to identify the species of a pathogen and its drug-resistance profile without the need for culture, providing physicians with vital information to speed the appropriate treatment of serious drug-resistant bacterial infections in hours rather than days.
In addition to the initial $6.2-million award, Day Zero will be eligible for an additional $18.7 million from CARB-X if the project meets certain development milestones, for a total award of up to $24.9 million, plus access to expertise and business consulting resources. This is the 60th project funded by CARB-X since it was established in 2016. CARB-X has invested more than $220 million so far to support innovative antibacterial research around the world during that time, and has committed millions more for projects that achieve milestones.
“This is the first whole-genome sequencing and machine learning technology in the CARB-X portfolio, and an exciting new diagnostic approach,” said Erin Duffy, Chief of Research and Development at CARB-X. “New technologies, like the diagnostic under development by Day Zero, if successful, could transform the way the way physicians diagnose and treat drug-resistant infections, and save lives.”
Rapid diagnostics urgently needed
The world’s ability to address the growing threat of antibiotic resistance is severely limited by current diagnostic approaches. Currently, hospital patients with suspected bloodstream infections or sepsis are treated with broad-spectrum antibiotics while physicians wait for laboratory results, which often take multiple days. The use of broad-spectrum antibiotics can make subsequent culture-based diagnostic tests less sensitive and can also contribute to the growth of antibiotic resistant organisms. Recent studies show that 20% of deaths globally are associated with sepsis, a life-threatening, unregulated immune response to severe bloodstream infections. In the United States, sepsis kills 270,000 patients annually, accounting for a third of all hospital deaths in the country. Septic shock is quick to kill, with the risk of death increasing almost 8% for each hour an infection goes without appropriate treatment.
“Over 2.8 million antibiotic resistant infections occur each year in the United States. These infections are often associated with severe sepsis cases, are extremely lethal, and often implicated in healthcare facility and community outbreaks. The ongoing COVID-19 pandemic is one of the most dramatic demonstrations the world has ever seen of the need for rapid and accurate diagnostics to effectively combat infectious diseases and offers important lessons for addressing antibiotic resistance,” said Jong Lee, CEO of Day Zero Diagnostics. “Through its funding programs, CARB-X is fueling the advancement of innovative approaches to combat antibiotic resistance, including technologies like ours that will use sequencing and large-scale data analysis to modernize infectious disease diagnostics.”
New approach to ID multiple bacteria
Day Zero is developing a diagnostic system to help physicians accurately diagnose life-threatening infections so patients can receive the most effective antibiotic treatment on the first day they are admitted to the hospital—day zero—rather than being treated with multiple days of toxic broad-spectrum antibiotics. The diagnostic is intended to sequence the bacterial DNA directly from a patient’s blood sample without the need for a time-consuming culture. The company’s proprietary machine learning algorithm will then analyze the genomic data to identify the species of the infection and determine its antibiotic susceptibility and resistance profile within hours, allowing physicians to confidently and quickly prescribe the most effective antibiotic to treat it. This approach will allow for the simultaneous testing of a broad range of bacterial species and their antibiotic susceptibility instead of just one species, or a handful of species, like current diagnostic approaches.
The initial CARB-X award will support the optimization of Day Zero’s sample preparation solution, sequencing technology, database development, and predictive algorithms. If the company achieves certain milestones, it will be eligible for additional funding to support full product engineering and system development for an automated, cartridge-based diagnostic system.
Day Zero is currently best known for its epiXact® service that uses whole-genome sequencing to help hospitals investigate infection outbreaks that may be occurring in their facilities. A recent article in the New England Journal of Medicine highlighted the use of Day Zero’s genome-sequencing service in helping Massachusetts General Hospital researchers identify the cause of a patient death that resulted from a fecal transplant.
Supporting innovation to address the global drug resistance crisis
The World Health Organization (WHO) estimates that 700,000 people die each year worldwide from drug-resistant bacterial infections.
With the world’s largest and most diverse portfolio, CARB-X currently supports the early development of 38 innovative antibiotics, vaccines, rapid diagnostics and other products to address drug-resistant bacteria.
CARB-X is a consortium led by Boston University and funded by a global partnership. CARB-X is investing up to US$500 million in antibacterial R&D between 2016-2021. The goal is to support projects through the early phases of development through Phase 1, so that they will attract additional private or public support for further clinical development and approval for use in patients. The scope of CARB-X funding is restricted to projects that target drug-resistant bacteria highlighted on the Centers for Disease Control and Prevention (CDC)’s 2013 Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO in 2017 – with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.
This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from Wellcome Trust and Germany’s Federal Ministry of Education and Research. The contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Office of the Assistant Secretary for Preparedness and Response, or other CARB-X funders.
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Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (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 that address drug-resistant bacteria. 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. carb-x.org/. Follow us on Twitter @CARB_X.
About Day Zero Diagnostics
Day Zero Diagnostics, Inc., based in Boston, is pioneering a new class of infectious disease diagnostics using whole genome sequencing and machine learning to revolutionize how the world fights the growing threat of antibiotic-resistance. The company’s mission is to change the way infectious diseases are diagnosed and treated by rapidly identifying both the species and the antibiotic resistance profile of severe infections without the need for a culture. By using sequencing, Day Zero also enables big data approaches to managing healthcare associated infection outbreaks. Day Zero Diagnostics was founded in 2016 by a team of clinicians and scientists from Harvard University and Massachusetts General Hospital. The company has been recognized as a leading innovator by MedTech Innovator, TedMed Hive, Xconomy, HealthTech Arkansas, and MassChallenge HealthTech. For more information visit www.dayzerodiagnostics.com or follow us on Twitter at @dayzerodx.
About BARDA and NIAID
The 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)
Education 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 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 firstname.lastname@example.org. www.bu.edu.