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CARB-X funds Scout to develop a low-cost point-of-care diagnostic for gonorrhea

CARB-X funds Scout to develop a low-cost point-of-care diagnostic for gonorrhea

Scout aims to expand access to STI testing by providing affordable, accurate, and convenient STI testing

(BOSTON: April 18, 2024) – Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award up to US$1 million to diagnostics and health tech company Scout to demonstrate proof-of-concept and feasibility ahead of development of a new point-of-care test – STI Scout. The test will detect and differentiate between Neisseria gonorrhoeae (Ng) and Chlamydia trachomatis (Ct). STI Scout is quick and inexpensive, with a turnaround time of 30 minutes and costs anticipated to be less than half of other options.

Additionally, STI Scout can use either first void urine or vaginal swabs, and future tests will be able to guide therapy for gonorrhea treatment based on antibiotic susceptibility. STI Scout uses the Scout Hub to run and the Scout Connect mobile app, which provides instructions, tracks results, and eventually will allow patients to connect digitally to a healthcare provider.

Scout is leveraging their patented Loop-de-Loop chemistry, a proven isothermal technology that was validated for highly accurate SARS-CoV-2 detection with Scout’s system, which has an FDA Emergency Use Authorization for point-of-care settings and an authorization for use in over-the-counter (OTC) settings pending. The CARB-X award will help Scout expand its test menu to offer simple and efficient point-of-care testing at STI clinics and urgent care centers and as a potential future option, an at-home test for STIs.

Gonorrhea is the second most reported bacterial STI. Approximately 82 million people were infected globally in 2020, with the highest prevalence of infection in low- and middle-income countries (LMICs). 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.

Decentralizing testing could greatly benefit patients particularly in low-resource settings, as clinics and urgent care centers could have fast, accurate, and affordable tests enabling same-day results which would expedite appropriate treatment. Notably, the low-cost design of the consumables and simple-to-use interface could enable Scout’s test to be used globally, expanding access to Ng testing to the lowest levels of the healthcare system including in LMICs. With further development, the Scout system tests also could be used at home, which is especially valuable among patient populations that are testing routinely.

“There is a need for affordable, accurate, and easy-to-use tests that expand access to testing for and proper treatment of Neisseria gonorrhoeae to urgent care centers, STI clinics, and the like”, said Erin Duffy, PhD, R&D Chief of CARB-X. “Given the prevalence of gonorrhea globally, and the growing prevalence of drug-resistant gonorrhea, to diagnose quickly and affordably would allow physicians at all levels of the healthcare system to treat rapidly with the most appropriate therapy. The impact of a test like Scout’s could be vast.”

“Our goal is to improve access to accurate diagnostics for everyone. Scout’s approach benefits clinicians and patients by providing timely, accurate results which can lead to earlier diagnosis and treatment of patients. Importantly, STI Scout also could assist healthcare providers in determining which treatments are appropriate for the patient and can assist combating the spread of antibiotic-resistant bacteria,” said Cam Ball, PhD, Scout CTO and Co-Founder.

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 bacterial infections, including those that have become resistant to antibiotics. CARB-X emphasizes performance characteristics that will allow the broadest use of these products against infections driving the greatest global morbidity and mortality.

When CARB-X was founded in 2016, the early-stage antibiotic pipeline was stalled. Since then, CARB-X has supported 101 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 nine product developers with active R&D projects already have secured advanced development partnerships which can help support their clinical development after leaving the CARB-X portfolio.

In 2022, 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, which kills 2.5 million infants annually; and oral therapeutics, vaccines and rapid diagnostics for gonorrhea. Scout’s diagnostic is the second diagnostic and ninth project 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 this year.

CARB-X funding for this research is supported by 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; under agreement number 75A50122C00028, and by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care as part of 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

Scout Contact: Jared Hsu, press@scouthealth.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 Scout

Scout is a US-based health technology and diagnostics company focused on the development of innovative diagnostic solutions for at-home and point-of-care use. The company’s platform technology facilitates the rapid development of molecular diagnostic tests that are both accurate and cost-effective. Scout’s integrated system includes the Scout Hub, the Scout Connect mobile application, and single-use Scout Test Kits. Currently, Scout’s product pipeline targets respiratory health, sexual health, and women’s health, among other areas. Previously known as Uh-Oh Labs, Scout received FDA Emergency Use Authorization for its COVID-19 test in clinical settings, with its over-the-counter version presently under FDA review. The company has garnered support and funding from several prestigious institutions, including the NIH’s Rapid Acceleration of Diagnostics (RADx) initiative, the NIH’s Point-of-Care Technologies Research Network (POCTRN), the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), and Y Combinator. For additional information, visit scouthealth.com. Follow Scout on Instagram and X @tryoutscout

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 Germen 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 UK 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 and international 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.

www.novonordiskfonden.dk/en

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.eduwww.bu.edu