SpeeDx’s rapid molecular diagnostic would detect an infection and determine the susceptibility of Neisseria gonorrhoeae to easy-to-access antibiotics
(BOSTON: May 10, 2021) – CARB-X is awarding SpeeDx, a diagnostics company in Sydney, Australia, up to $1.8 million to develop a rapid test for Chlamydia trachomatis and Neisseria gonorrhoeae, sexually transmitted bacteria that can cause serious infections and that are spreading around the world at alarming rates. SpeeDx is also eligible for $1.9 million in additional funds from CARB-X if the project achieves certain milestones, subject to available funds.
SpeeDx has developed a rapid, molecular test using polymerase chain reaction (PCR) technology called InSignia™, that is able to identify whether an active infection is associated with Chlamydia trachomatis or Neisseria gonorrhoeae. Additionally, through susceptibility testing, the technology will identify the best-available antibiotic choice for treatment of gonorrhea. SpeeDx’s technology would be combined with a battery-powered, simple-to-use device developed by another company, QuantuMDx, that could be used in remote or low-resource settings around the world as a point-of-care diagnostic. The SpeeDx technology would be ported onto the QuantuMDx Q-POC™. The goal is to develop an affordable test, rapid (60 minutes) that will both detect the causative bacteria and identify which antibiotic — from among orally administered antibiotics that are generally readily available in low-and middle-income countries (LMICs) — is best for treating the infection.
“SpeeDx’s technology is in the early stages of development and, if successful, could be used to help health-care providers rapidly diagnose chlamydia and gonorrhea, and to identify antibiotics that could be effective, thus improving treatment decisions, and mitigating the devastating effects of these diseases,” 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. “Treating gonorrhea is increasingly challenging, and in some cases not possible because Neisseria gonorrhoeae, the causative agent of gonorrhea, has developed resistance to most existing antibiotics. Faster diagnostics have the potential to help inform treatment decisions, and those diagnostics that can be deployed in low-resource settings are sorely needed.”
“We are adapting our recently developed InSignia technology in close collaboration with QuantuMDx with a goal to supply affordable and innovative diagnostics, and significantly improve the standard of care and antibiotic stewardship in the management of sexually transmitted infections. The support from CARB-X for this venture will help accelerate this development and extend access in critical need areas,” said Colin Denver, SpeeDx CEO.
Growing challenge world-wide
Drug-resistant Neisseria gonorrhoeae, often referred to as “super gonorrhea”, are bacteria identified by the World Health Organization (WHO) as “high priority” pathogens, and are classified by the US Centers for Disease Control and Prevention (CDC) as an “urgent” public health threat that requires aggressive action. Rapid detection of infection and antibiotic-resistance are key to improving patient outcomes and curbing the spread of disease and bacteria.
The WHO estimates that each year 78 million people are infected with gonorrhea globally and the US CDC reports roughly 1.14 million new cases occur in the US annually, of which an estimated 550,000 involve drug-resistant bacteria. At the global level, gonorrhea is principally a disease of LMICs, and disproportionately affects women who are less likely than men to have symptoms and thus seek care. Since healthcare facilities in LMICs are often sparse and ill-equipped, particularly in the poorest countries of sub-Saharan Africa, the vast majority of infections go untreated. Rapid diagnostics can potentially help improve care.
Supporting global innovation to address antibiotic resistance
The CARB-X portfolio is the world’s largest and most diverse antibacterial R&D portfolio with 57 active projects, including 11 rapid diagnostics, focused exclusively on drug-resistant bacteria. 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 87 awards worth more than $326.8 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.
Each year, an estimated 700,000 people die each year from antibiotic-resistant infections. 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 Administration for Strategic 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 Administration for Strategic 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.
Founded in 2009, SpeeDx is an Australian-based private company with offices in London and the US, and distributors across Europe. SpeeDx specializes in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. Innovative real-time polymerase chain reaction (qPCR) technology has driven market-leading multiplex detection and priming strategies. Product portfolios focus on multiplex diagnostics for sexually transmitted infections (STIs), antibiotic resistance markers and respiratory conditions. Resistance Guided Therapy improves patient outcomes by empowering practitioners to make informed clinical decisions. https://plexpcr.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).
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 firstname.lastname@example.org. www.bu.edu.