New portable battery-powered diagnostic is designed to be easy-to-use in any setting around the world
(BOSTON) – CARB-X is awarding Novel Microdevices, Inc. of Baltimore, Maryland, USA, up to $3.6 million in non-dilutive funding, and, subject to available funding, up to an additional $10.2 million if certain project milestones are met, to develop a new rapid molecular test to diagnose sexually-transmitted bacterial infections, including Chlamydia trachomatis and Neisseria gonorrhoeae. Novel’s new device would diagnose infections in about 25 minutes from a vaginal swab or urine sample, and detect antibiotic-resistant bacteria, including those resistant to ciprofloxacin and 3rd generation cephalosporins, the only antibiotics that are still effective as treatments for most strains of the gonorrhoeae bacteria.
“Treating gonorrhea is challenging and in some cases not possible because Neisseria gonorrhoeae, the causative agent of gonorrhea, has developed resistance to most existing antibiotics,” 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. “Novel’s technology is in the early stages of development and, if successful, could be used world-wide to help health-care providers diagnose gonorrhea, including resistance markers, more rapidly, thus improving treatment decisions, and mitigating the devastating effects of these diseases.”
Novel’s rapid point-of-care diagnostic is designed for portability, weighing only four pounds. It is battery powered, making it particularly suited to low resource healthcare settings and low-and middle-income countries (LMICs). The molecular testing platform was developed to overcome one of the challenges of point-of-care diagnostics – the sample preparation step. With Novel’s approach, the patient sample is simply added to a disposable cartridge, which is then inserted into the Novel Dx system, which analyzes the genetic sequence of cells to identify disease and the presence of genetic mutations known to make bacteria resistant to antibiotics.
“Novel’s innovative diagnostic technology is rapid, affordable, highly accurate
and robust. Our collaboration with CARB-X aims for quick and accurate diagnoses in all settings including usage by professionals, laypeople and in underdeveloped areas,” said Andrea Pais, Novel Microdevices’ CEO.“This has the potential to transform treatment decisions and save lives. CARB-X’s investment and expertise invigorates Novel’s momentum, and we are determined in our shared mission of addressing the growing challenge of antibiotic-resistant bacteria.”
Drug-resistant Neisseria gonorrhoeae, often referred to as “super gonorrhea”, are identified by the World Health Organization (WHO) as a “high priority” pathogen, 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 about 78 million people a year have gonorrhea; roughly 1.14 million cases occur in the US, 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. 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 such as the Novel device can potentially help improve care.
Supporting global innovation to address antibiotic resistance
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.
The CARB-X portfolio is the world’s largest and most diverse antibacterial R&D portfolio with 54 active projects focused exclusively on drug-resistant bacteria, including eight rapid diagnostics projects. 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 innovative 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 83 awards worth more than $308.8 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 research projects in this news release are 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 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). 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 Novel Microdevices
Novel Microdevices is commercializing an ultraportable point-of-care molecular diagnostics product line to address the urgent needs of under-served healthcare settings for rapid, accurate, and cost-effective diagnostic testing solutions for infectious diseases. The Novel Dx technologies were designed from the ground up with the goal of converting the complex molecular diagnostic tests traditionally performed in centralized reference labs into simpler point-of-care tests, while maintaining the same high accuracy. The fully automated sample-to-answer Novel Dx molecular diagnostic platform allows for safe on-board handling of specimens in disposable and fully self-contained microfluidic test cartridges. Novel’s rugged platform is adaptable to a wide range of diseases and healthcare settings as it accommodates a diverse variety of complex clinical samples and delivers multiple test results from a single multiplexed test cartridge. The lightweight battery-powered Novel Dx platform and individually packaged test cartridges can be used in the most remote settings, aiding healthcare providers to rapidly diagnose and provide their patients with the most appropriate antimicrobial therapies. https://noveldx.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.