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Introduction
The use and misuse of antibiotics contribute to the rise in drug-resistant bacteria—a serious and worsening threat to human health. Addressing the problem of antibiotic resistance requires measures to spur innovation and ensure the prudent use of existing drugs. The development and use of rapid point-of-care diagnostics in the healthcare setting plays an important role in avoiding unnecessary use of antimicrobials by providing clinicians with the right information at the right time to help them make decisions about appropriate drug treatment for patients. Diagnostics also have the capacity to support early detection and diagnosis of drug-resistant bacterial infections, enable disease surveillance, and help prevent disease spread.
On October 13th and 14th of 2022, a workshop entitled Accelerating the Development and Uptake of Rapid Diagnostics to Address Antibiotic Resistance was convened by the National Academies’ Forum on Drug Discovery, Development, and Translation;1 the Forum on Medical and Public Health Preparedness for Disasters and Emergencies;2 and the Forum on Microbial Threats.3 The workshop provided a venue for stakeholders to discuss the current landscape of rapid diagnostics and to address antibiotic resistance, consider challenges and opportunities for spurring innovation, and consider practical next steps for accelerating the development and
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1 See https://www.nationalacademies.org/our-work/forum-on-drug-discovery-development-and-translation (accessed January 25, 2023).
2 See https://www.nationalacademies.org/our-work/forum-on-medical-and-public-health-preparedness-for-disasters-and-emergencies (accessed January 25, 2023).
3 See https://www.nationalacademies.org/our-work/forum-on-microbial-threats (accessed January 25, 2023).
uptake of new diagnostic tools. Given the breadth and depth of the issues related to diagnostic development and use, the focus of this workshop was on U.S.-based healthcare settings, policies, and incentives. Workshop participants discussed some of the global implications and considerations as well, which merit further time and attention.
Kent E. Kester (Vice President, Translational Medicine, International AIDS Vaccine Initiative) and Betsy Wonderly Trainor (Alliance Director, CARB-X), welcomed workshop participants, some of whom attended in person in Washington, D.C., and some virtually. Trainor began by sharing her thoughts on the issue and emphasized that the use and misuse of antibiotics continues to contribute to the rise in drug-resistant bacteria. Antibiotic resistance—which occurs when bacteria develop the “ability to overcome the effects of drugs designed to kill or disarm them—is one of the greatest public health threats” today, said Trainor. According to the World Health Organization (WHO), over 700,000 annual deaths worldwide can be attributed to drug-resistant bacterial infections, and this number is growing (WHO, 2019).4 To keep up with antibiotic resistance, researchers need to produce several innovative antibiotics every decade, but it currently takes between 10 and 15 years to produce a single new antibiotic (WHO, 2022a). Addressing the problem of antibiotic resistance requires not only measures to accelerate the discovery and development of new antibiotics but also efforts to ensure that existing antibiotics are properly used and prescribed.
Rapid diagnostics can play a crucial role in reducing the unnecessary use of antibiotics, said Trainor, by providing clinicians with the right information at the right time so they can make better decisions about appropriate treatment for patients. Additionally, early detection and diagnosis of drug resistant bacterial infections can further enable disease surveillance and help prevent disease spread. There are several rapid diagnostics available today, and more are in the pipeline, but few have been adopted by the healthcare system. Trainor suggests several reasons for the lack of uptake, including regulatory hurdles, misaligned economic incentive, and health inequities. Addressing the problem of antibiotic resistance, she said, will require innovative approaches and cross-sector collaborations that bring together the scientific, medical, regulatory, diagnostic, pharmaceutical, payer, and patient advocacy communities.
The workshop was planned according to a Statement of Task (Box 1-1) and builds upon previous works of the National Academies, including past
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4 To view the WHO report, see https://www.who.int/news/item/29-04-2019-new-report-calls-for-urgent-action-to-avert-antimicrobial-resistance-crisis (accessed March 13, 2023). Other estimates suggest deaths associated with AMR are much higher; see https://doi.org/10.1016/S0140-6736(21)02724-0 (accessed March 13, 2023).
workshops on Antibiotic Resistance: Implications for Global Health and Novel Intervention Strategies (2010); Technological Challenges in Antibiotic Discovery and Development (2014); and Combating Antimicrobial Resistance: A One Health Approach to a Global Threat (2017). In addition to these workshops, a recent National Academies consensus report, titled Combating Antimicrobial Resistance and Protecting the Miracle of Modern Medicine (2022), offered recommendations for improving the detection of resistant infections, incentivizing the development of drugs and diagnostics, and the role of the United States in coordinating global action to combat
microbial resistance. While much work has been done in this space, Kester emphasized that “more needs to be done.”
This workshop proceedings largely follows the organization of the workshop agenda, found in Appendix A. All speaker biographies can be found in Appendix B. Chapter 2 provides an overview of the current state of rapid diagnostics and examines how these tools might fit into the healthcare system. Chapter 3 summarizes discussions about challenges and opportunities for the development and use of rapid diagnostics. Chapter 4 examines incentives and disincentives for the development of new antibiotics and complementary diagnostics, and Chapter 5 considers health equity implications in this area. Chapter 6 explores approaches to facilitate the adoption of rapid diagnostics by health care systems, including integration with antibiotic stewardship programs. Finally, Chapter 7 looks at the path forward, summarizing input from workshop participants on practical and potential opportunities for spurring the development and use of rapid diagnostics in healthcare settings.
