Rapid easy-to-use diagnostic would indicate which antibiotics would be effective against the bacterial pathogen causing the UTI
(BOSTON) – CARB-X announced today it is awarding Module Innovations of Pune, India, up to US$702,000 plus up to $2.5 million more if certain project milestones are met, to develop a rapid diagnostic for drug-resistant urinary tract infections (UTI). The diagnostic would also provide vital information on which antibiotics would be most effective against the superbug, including common uropathogens such as Escherichia coli, Klebsiella, Pseudomonas aeruginosa and Enterococci faecalis that often cause infection.
The phenotypic test, ASTSENSeTM for rapid antibiotic susceptibility testing (AST) of UTIs, would shave days off the time it takes to diagnose a UTI. A simple, non-invasive urine sample would be loaded into the ASTSENSe device, which would diagnose an infection and provide the antibiotic resistance profile of the pathogen(s) involved within two hours.
“Rapid diagnostics, like those accessible through Module’s technology, are urgently needed to help ensure that UTI patients in developed and developing countries receive effective treatment as quickly as possible,” said Erin Duffy, Chief of Research and Development at CARB-X, a global non-profit partnership led by Boston University and funded by governments and foundations focused on supporting the development of new products to address the rise of drug-resistant bacteria. “This technology, if successful, could provide health professionals with fast, accurate, and affordable AST information for UTIs, accelerating the delivery of effective therapeutics to patients, saving lives, and reducing the risk of contributing to drug resistance.”
Currently, diagnosing a UTI and providing AST results can take days and requires advanced microbiology laboratories and personnel. Patients are usually prescribed broad spectrum antibiotics while waiting for test results. This approach often does not work, particularly as infections are increasingly caused by drug-resistant pathogens. Inappropriate therapy can increase the risk of sepsis, referred to as urosepsis, kidney damage, and other health-complications related to serious UTIs. As well, inappropriate use of antibiotics can contribute to drug-resistance. Affordable and rapid bacterial ID and AST technology could enable data-driven decision making and appropriate antibiotic use particularly in low- and middle-income countries (LMICs), improving patient outcomes and antibiotic stewardship.
Drug-resistant UTIs a growing threat
“UTIs are a severe problem affecting millions of people globally. Slow diagnostics are a major obstacle in the effective treatment of patients,” said Sachin Dubey, CEO and Co-Founder of Module Innovations. Module is the first Indian diagnostics developer to be funded by CARB-X, and the second Indian biotech to be selected for support. “This funding and expert support from CARB-X will help us develop the ASTSENSe technology and, if successful, save lives by speeding up the diagnosis and effective treatment of deadly UTI infections,” he said.
The ASTSENSe test works in conjunction with the company’s USENSeTM bacterial identification test. The device is no bigger than a small printer, and Module designed it for use in a variety of health-care settings, particularly in LMICs. The technology works by monitoring change in the size of Module’s proprietary nanoparticle complex that is mixed with the urine sample when running the test in the ASTSENSe cartridge. The size of these complexes is directly proportional to bacterial growth. The results are displayed on the ASTSENSe screen and can also be delivered to a clinician’s phone.
A UTI is an infection of the bladder, kidneys, ureters, or urethra that occurs when bacteria enter the urinary system. It is one of the most common infections globally, affecting females more than males due to the anatomy of the bladder and urethra, and increasingly involved drug-resistant bacteria. In LMICs, it is a significant problem among pregnant women.
There are an estimated 150 million UTI cases globally each year. Global UTI mortality rates are not available. In the US, 13,000 deaths are attributed directly to UTIs each year, and the number is higher when patients develop bloodstream infections as a result of the UTI.
Supporting innovation to address the global superbug crisis
The CARB-X portfolio is the world’s largest and most diverse antibacterial development portfolio with 41 active R&D projects focused exclusively on drug-resistant bacteria. CARB-X is investing up to $500 million in non-dilutive funding between 2016-2021 to support the development of new antibiotics, rapid diagnostics, vaccines and other life-saving products that address drug-resistant bacteria. 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 approval for use in patients.
Since its launch in 2016, CARB-X has announced 63 awards exceeding $232.1 million, with the potential of additional funds if project milestones are met, to accelerate the development of antibacterial products. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and others fail for a variety of reasons.
This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by award from 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.
Sachin Dubey, CEO and Cofounder
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. 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.
Module Innovations is a medical technology company developing rapid diagnostics for Identification and antibiotic susceptibility test (ID/AST) of uropathogens causing urinary tract infections (UTI). Module is leveraging its proprietary size dependent signal amplification by nanoparticles (SDSAN) technology to develop tests for bacterial ID and AST. The ASTSENSe device will determine antibiotic susceptibility of major uropathogens including E. coli, Klebsiella, Pseudomonas aeruginosa and Enterococci spp. Module is thus paving way for rapid and cost-effective pathogen ID and AST testing with the aim to combat the rising problem of antimicrobial resistance (AMR). Module is headquartered in Pune, India. Follow us on Twitter at @moduleinno. Or visit www.moduleinnovations.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).
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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 email@example.com. www.bu.edu.