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CARB-X is funding UK-biotech GenomeKey to develop a rapid diagnostic for sepsis, a leading cause of death in hospitals

CARB-X is funding UK-biotech GenomeKey to develop a rapid diagnostic for sepsis, a leading cause of death in hospitals

Innovative technology combines DNA extraction and sequencing with machine learning DNA interpretation

(BOSTON) – CARB-X is awarding GenomeKey (Genomics Labs Ltd.) in Bristol, UK, up to $3.0 million in non-dilutive funding to develop an innovative rapid diagnostic for sepsis. GenomeKey is eligible for up to $6.5 million in additional awards if the project achieves certain milestones, subject to available funds.

The new diagnostic would significantly reduce the time it takes to determine what bacteria are causing an infection and which antibiotics would be most effective in treating a patient suffering from sepsis. The diagnostic would deliver precise test results in four hours rather than the several days it can currently take. Faster diagnosis would enable appropriate treatment to be administered more quickly, a critical step for improving outcomes and saving lives in sepsis cases.

Sepsis is a leading cause of hospital deaths in many countries. Globally, an estimated 11 million people die each year from sepsis. Recent studies report that sepsis kills at least 46,000 people per year in the UK with potential direct costs to the UK National Health System at more than £1.8 billion per year. In the US, the toll is similar. An estimated 1.7 million American adults develop sepsis each year and nearly 270,000 die as a result, according to the US Centers for Disease Control and Prevention (CDC).  This represents an estimated health care cost in the US of $62 billion annually.

“Prompt diagnosis and treatment provide the best chance for reducing death rates and improving recovery from sepsis,” said Erin Duffy, R&D Chief of CARB-X, a non-profit global partnership led by Boston University and dedicated to supporting the development of innovative therapeutics, preventatives and diagnostics to address antibiotic-resistant bacterial infections. “GenomeKey’s innovative technology aims to accelerate diagnosis and deliver vital antibacterial susceptibility information that could take the guesswork out of treatment decisions in the first critical hours of illness.”

Studies show that the risk of dying from sepsis increases by as much as eight per cent for every hour that treatment is delayed. Currently, it can take between 24 and 72 hours for laboratories to produce results.

“The technology GenomeKey is building will enable clinicians to diagnose and treat sepsis faster, and reduce unnecessary antibiotic consumption. Sepsis can kill within hours, and yet the gold standard test for this disease currently takes days,“ said Dr. Michael Roberts, GenomeKey CEO. “At GenomeKey, we are changing this by combining advances in DNA sequencing with our unique genomic technology and machine learning to deliver a next-generation diagnostic that will provide clinical answers in only hours, and enable clinicians to confidently put their patients on targeted antibiotics sooner.”

Innovative technology

GenomeKey’s diagnostic project aims to accurately determine the presence of bacteria from a blood sample, identify the bacterial species and determine its antibacterial susceptibility, all within a matter of hours. The technology combines innovative methods to separate bacterial DNA from human DNA in whole blood, next generation DNA sequencing and innovative machine learning to interpret the antimicrobial susceptibility of the bacterial DNA.

Sepsis is a life-threatening condition that occurs when a patient’s immune system overreacts to an infection that has entered the bloodstream. In normal circumstances, immune defenses are capable of fighting off invading bacteria and viruses, but in sepsis, the invading pathogens overcome these defenses, leading to rapid deterioration of the patient’s condition, and potentially to organ failure and death. Administration of the appropriate treatment early on, for example an antibiotic known to be effective against the bacteria, is vital. Some people are at higher risk of contracting infection and developing sepsis. These include the very young, the very old, those with chronic illnesses, and those with a weakened or impaired immune system.

Supporting global innovation to address antibiotic resistance

The CARB-X portfolio is the world’s largest and most diverse antibacterial R&D portfolio with 56 active projects focused exclusively on drug-resistant bacteria, including 10 rapid diagnostics. CARB-X is investing up to $480 million in non-dilutive funding between 2016-2022 to support the early development of new antibiotics, vaccines, rapid diagnostics and other life-saving products. The goal is to support projects through the early phases of development so that they will attract additional private or public support for further clinical development and regulatory approval for use in patients.

Since its launch in 2016, CARB-X has announced 86 awards worth more than $325 million, with the potential of additional funds if project milestones are met, subject to available funding. These funds are in addition to investments made by the companies themselves.

Antibiotic resistance represents one of the world’s great public health threats. Each year, an estimated 700,000 people die each year from antibiotic-resistant infections, including 35,000 in the US and 33,000 in Europe. CARB-X funds only projects that target drug-resistant bacteria highlighted on the CDC Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.

CARB-X funding for this research is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from the Wellcome Trust and Germany’s Federal Ministry of Education and Research (BMBF). The contents of this news release 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.

Contacts:

CARB-X
Jennifer Robinson
+1 514 914 8974
carbxpr@bu.edu

GenomeKey
Dr. Michael Roberts, CEO
michael@genomekey.com

About CARB-X
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).  CARB-X is investing up to $480 million from 2016-2022 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. carb-x.org/.  Follow us on Twitter @CARB_X. 

About GenomeKey
GenomeKey is an award-winning, early phase company which is exploiting innovative genomic technology and cutting-edge AI machine learning to address critical healthcare challenges. The company is developing a medical device to dramatically reduce the time to diagnose sepsis and at the same time to rapidly inform the best treatment.  This low-cost device will save lives, save money and help to reduce the risk of emerging bacterial drug resistance. www.genomekey.com

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).

About BMBF
Education and research are the foundations for our future. The promotion of education, science and research by the German 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 jeremy22@bu.edu. www.bu.edu.