Day Zero Diagnostics Awarded $6.2 Million in CARB-X Funding for Development of New Technology to Rapidly Diagnose Superbug Infections and Determine the Most Effective Antibiotic for Treatment

New diagnostic system will combine whole-genome sequencing and machine learning to identify a pathogen and its drug-resistance profile within hours, not days

BOSTON--(BUSINESS WIRE)-- Day Zero Diagnostics, Inc., an infectious disease diagnostics company using genome sequencing and machine learning to combat the rise of antibiotic-resistant infections, today announced it was awarded up to $6.2 million in non-dilutive funding from Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership dedicated to accelerating early antibacterial research and development to address the rising global threat of drug-resistant bacteria.

Funds will support the development of Day Zero’s diagnostic system that is intended to help physicians quickly and accurately diagnose and treat life-threatening bacterial infections. The system promises to help patients with severe infections 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 to prevent septic shock.

Day Zero’s diagnostic system is designed to extract bacterial DNA directly from a patient sample, such as blood, for sequencing, without the need for a time-consuming culture. The company’s proprietary machine-learning algorithm then analyzes the genomic data to identify the pathogen and determine its antibiotic susceptibility and resistance profile within hours, allowing physicians to confidently and quickly prescribe the most effective antibiotic treatment. The system is designed to allow for the simultaneous testing of a broad range of bacterial species and their antibiotic susceptibility instead of just a handful of species, like current molecular diagnostic approaches.

In addition to the initial $6.2 million award, the company 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 in cash plus access to expertise and business consulting resources.

“There has never been a more dramatic demonstration of the importance of rapid and accurate diagnostics to combat infectious disease threats than the current COVID-19 pandemic,” said Jong Lee, CEO of Day Zero Diagnostics. “Antibiotic-resistant infections can be extremely lethal, spread easily and persistently in healthcare institutions, and they continue to grow as a global threat. We are pleased to have CARB-X’s support to develop a new class of culture-free, sequencing-based diagnostics that can modernize the fight against these dangerous infections.”

Day Zero’s diagnostic system holds promise to not only improve the outcomes for individual patients, but also to transform how hospitals monitor transmission events within their institutions, track the evolution of antibiotic resistance, and prepare for potential outbreaks. By aggregating and analyzing the genomes and resistance profiles of pathogens sequenced by the diagnostic system in real-time, the company will be able to offer unprecedented visibility into the proliferation of resistant organisms, identify and predict outbreaks within hospitals and regions, and help identify potential targets for developing new antibiotics.

“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.”

Funding from CARB-X will enable Day Zero to complete development of the core technologies that will power its diagnostic system, including Blood2Bac™, a proprietary sample preparation technology for ultra-high enrichment of bacterial DNA from clinical blood samples and Keynome^®, Day Zero’s machine learning algorithm for species identification and resistance profiling. The company will also continue to expand MicrohmDB^®, a proprietary large-scale database combining pathogen genomic sequences with their known antibiotic resistance and susceptibility profiles.

About Antibiotic Resistance

Antibiotic resistance is an ongoing crisis that causes at least 700,000 global deaths annually.¹ By 2050, this figure is expected to grow to 10 million.¹ The growth of severe, drug-resistant infections will also lead to increased deaths from sepsis, a life-threatening, unregulated immune response to severe bloodstream infections. Recent studies show that 20% of deaths globally are already associated with sepsis.² Today, preventing septic shock relies on treating patients with broad-spectrum antibiotics because the risk of death from sepsis increases by almost 8% for each hour an infection goes without appropriate treatment.³ This practice can make subsequent culture-based diagnostics less sensitive and can also contribute to the growth of antibiotic-resistant organisms. Without innovative diagnostic approaches that bypass the need for time-consuming cultures, the world’s ability to address the growing threat of antibiotic resistance will be severely limited.

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 for 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 CARB-X

Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global non-profit partnership dedicated to accelerating early stage antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X is investing up to $500 million between 2016 and 2021 to support innovative antibiotics, vaccines, rapid diagnostics, and other life-saving products. CARB-X focuses exclusively on high-priority drug-resistant bacteria, especially Gram-negatives. 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 World Health Organization (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. CARB-X is led by Boston University. CARB-X 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 (HHS), 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 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). CARB-X is headquartered at Boston University School of Law. https://carb-x.org.

¹ https://www.who.int/antimicrobial-resistance/interagency-coordination-group/IACG_final_report_EN.pdf?ua=1
² https://www.thelancet.com/action/showPdf?pii=S0140-6736%2819%2932989-7
³ https://www.ncbi.nlm.nih.gov/pubmed/16625125

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