Prompt Diagnostics LLC to demonstrate rapid detection of ceftriaxone-resistant gonorrhea
(BOSTON: June 27, 2024) – Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is awarding Prompt Diagnostics LLC US$1 million to further the development of a portable PCR platform with high multiplexing capabilities that, if successful, detect multiple pathogenic bacteria targets and their antibiotic susceptibility which will help to guide treatment at the point-of-care. Prompt is a biotechnology firm that aims to provide fast, affordable, and easy-to-use diagnostics with high sensitivity and specificity for disease detection at the point-of-care.
The CARB-X award supports further development of Prompt’s technology, with focused attention on demonstrating feasibility to both detect gonorrhea and reliably characterize drug resistance through an array of genetic mutations, including those for third-generation cephalosporins. Their technology employs robust melt-curve analysis which could provide more options for reliable antibiotic susceptibility testing. If successful, Prompt’s approach could enable more effective treatment management and promote antimicrobial stewardship to prevent the development and spread of multi-drug resistant gonorrhea globally, particularly in low-resource settings with remote or limited access to secondary healthcare facilities.
“Prompt’s technology has the potential to efficiently detect the presence of ceftriaxone-resistant gonorrhea, which poses a growing and significant global public health risk,” said Erin Duffy, PhD, R&D Chief of CARB-X. “Rapid, sophisticated diagnostics are essential to addressing drug-resistant bacterial infections globally, as they detect infections as early as possible while also directing healthcare providers to the most appropriate treatment. We are enthusiastically partnering with Prompt to better understand the capabilities of their PCR platform and how it could support decentralized rapid ID and susceptibility testing for all of the major classes of antibiotics.”
Gonorrhea is the second most reported bacterial STI. Approximately 82 million people were infected globally in 2020, with disproportionately higher rates in low and middle income countries, where the burden of drug-resistance is highest. Patients with gonorrhea can face serious health effects, including pelvic inflammatory disease, chronic pelvic pain, and infertility. Since patients do not always exhibit symptoms, reported cases may only capture a fraction of the true burden.
“We are very excited to work with CARB-X to push our Prompt diagnostic platform to market,” said Co-Founder and CEO Alexander Trick, PhD. “In addition to funding, the expertise of the CARB-X team and collaborators will provide critical insight and guidance for product development and maximizing clinical impact.”
An estimated 1.27 million people died due to drug-resistant bacterial infections in 2019, a death toll that exceeded HIV/AIDS (864,000) and malaria (643,000) in that same year. CARB-X is building a pipeline of high-value products to prevent, diagnose and treat the most dangerous bacterial infections that have become resistant to antibiotics. CARB-X emphasizes performance characteristics that that patients need against infections driving the greatest global morbidity and mortality.
When CARB-X was founded in 2016, the early-stage antibiotic pipeline was stalled. Since inception, CARB-X has supported 104 R&D projects in 13 countries, and CARB-X product developers have made tremendous progress: 18 projects have advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and two diagnostic products have reached the market. Additionally, at least 9 product developers with active R&D projects have already secured advanced development partnerships which can help support their clinical development after leaving the CARB-X portfolio.
Last year, CARB-X launched new funding rounds to support R&D projects and fill critical gaps in the antibacterial pipeline. These include oral therapeutics to replace the workhorse antibiotics that are failing; vaccines for neonatal sepsis; and oral therapeutics, vaccines and rapid diagnostics for gonorrhea, given that resistant strains of gonorrhea have evaded all but one existing antibiotic. Prompt is the fourth diagnostic to receive a CARB-X award as part of the 2022-2023 funding call. Additional projects are under review, and new product developers will be announced this year. Register for the CARB-X newsletter to learn more about upcoming funding calls that will be announced.
CARB-X is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), the Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Public Health Agency of Canada (PHAC), the Bill & Melinda Gates Foundation, and the Novo Nordisk Foundation. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of any CARB-X funders.
CARB-X Contact: Marissa Novel, carbxpr@bu.edu
Prompt Diagnostics Contact: info@prompt-dx.com
About CARB-X
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. CARB-X funds only projects that target drug-resistant bacteria highlighted on the CDC’s 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. https://carb-x.org/ | X (formerly Twitter) @CARB_X
About Prompt
Prompt Diagnostics LLC is building a low-cost, portable platform that can deliver lab-quality diagnostics to guide treatment in any clinical setting. With gold standard PCR assays delivered in minutes, our tests will enable clinicians to prescribe targeted therapy during the first patient visit. Our tests miniaturize and automate sample extraction and amplification of DNA and RNA targets in affordable cartridges. High multiplexing capabilities allow the Prompt platform to not only identify multiple diseases simultaneously, but also genotype a wide variety of mutations to evaluate variants and predict antibiotic resistance in an era of rapidly evolving pathogens. Prompt platform development for an array of infectious diseases is currently supported by funding from the NIH, NSF, CDC, and Maryland Innovation Initiative. https://prompt-dx.com/ | https://www.linkedin.com/company/prompt-diagnostics/
About BARDA and NIAID
The U.S. 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. The Administration for Strategic Preparedness and Response (ASPR) leads the nation’s medical and public health preparedness for, response to and recovery from disaster and other public health emergencies. Within ASPR, the Biomedical Advanced Research and Development Authority (BARDA) invests in innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products – needed to combat health security threats and is one of the leading public sector funders of advanced development of antimicrobial therapeutics and diagnostics.
As part of HHS, NIH is the primary U.S. 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. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About Wellcome
Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.
About the German Federal Ministry of Education and Research (BMBF)
Education and research are crucial foundations for our future. Thus, the promotion of education, science and research is a policy priority of the German Federal Government. The German Federal Ministry of Education and Research (BMBF) strengthens education at all stages of life and provides support for scientific research and innovation.
About the Global AMR Innovation Fund (GAMRIF)
The Global AMR Innovation Fund (GAMRIF) is a One Health aid fund that supports research and development around the world to reduce the threat of antimicrobial resistance (AMR) in humans, animals and the environment for the benefit of people in low- and middle-income countries (LMICs). GAMRIF core objectives are to develop innovative One Health solutions to tackle AMR; increase availability of context-specific, accessible, and affordable innovations for LMICs; establish international research partnerships with industry, academia, and governments; and collaborate with and leverage additional funding from other global donors.
About the Public Health Agency of Canada
The Public Health Agency of Canada is an agency of the Government of Canada that is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention. Created in 2004 with a mission to promote and protect the health of Canadians through leadership, partnership, innovation and action in public health, the Agency’s activities focus on preventing disease and injuries, responding to public health threats, promoting good physical and mental health, and providing information to support informed decision making. The Agency has a long history of working with domestic andinternational partners on combatting health threats, including AMR. Most recently, the Agency released the Pan-Canadian Action Plan on AMR, a multijurisdictional effort that emphasizes One Health collaboration to make progress on AMR.
About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.
About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With nearly 37,000 students, it is the third-largest independent university in the United States. BU consists of 17 schools and colleges and the interdisciplinary Faculty of Computing & Data Sciences, 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 71 leading research universities in the United States and Canada. For further information, please contact Kim Miragliuolo at kmira@bu.edu. www.bu.edu