Accelerating the Development and Uptake of Rapid Diagnostics to Address Antibiotic Resistance

Defining the Need for Rapid Diagnostics

The National Academies of Sciences, Engineering, and Medicine’s Forum on Drug Discovery, Development, and Translation, Forum on Medical and Public Health Preparedness for Disasters and Emergencies, and Forum on Microbial Threats co-convened a public workshop on October 13 and 14, 2022, to discuss the current landscape of rapid diagnostics to address antibiotic resistance, consider challenges and opportunities for spurring innovation, and consider practical next steps for accelerating the development and uptake of new diagnostic tools.

Statements and opinions expressed are those of individual workshop presenters and participants.1

“Rapid diagnostics play a crucial role in avoiding unnecessary use of antibiotics. By providing clinicians with the right information at the right time, better decisions about the appropriate drug treatment for patients can be made.”

Betsy Wonderly Trainor
Alliance Director, CARB-X

“We have reached that moment in time when our supply of antibiotics can no longer keep pace with the organisms that defeat them so rapidly.”

Bradley Burnam
AMR Survivor and Founder, Turn Therapeutics

“We all know how central [diagnostics] are to public health, how essential they are to the longevity and stewardship of having antibiotics, and yet the market doesn’t value them that way.”

Phyllis Arthur
Vice President, Infectious Disease & Emerging Science Policy, BIO

The Role of Rapid Diagnostics

Rapid diagnostics play a crucial role in reducing the unnecessary use of antibiotics by helping health care providers make informed decisions about appropriate antibiotic treatment for their patients (Cohen, Trainor).

KEY POINTS

  • Providers have an ethical obligation to their patients to provide the right treatment at the right time, with full informed consent. The current system of antibiotic testing and treatment does not meet this obligation. (Cohen)
  • Antimicrobial stewardship and diagnostic stewardship are complementary practices that go hand in hand to guide therapeutic decisions. (Burnham)
  • Innovation involves risk, and partnerships between diagnostics and therapeutics companies can help distribute the risk. (Frank)
  • Partnerships between diagnostics and therapeutics companies can help optimize clinical trials by enabling the selection of patient population, saving time and cost, and limiting unnecessary patient drug exposure. (Raymond-Schwartzmann)
  • Teresa Gomez

    In Patient Care and Outcome

    “Diagnosing a patient earlier and treating earlier with an appropriate antibiotic can help reduce severe outcomes.”

    Kim Sciarretta
    DRIVe Launch Office Branch Chief, Biomedical Advanced Research and Development Authority (BARDA)

  • Lawrence Wetsit

    In Patient Care and Outcome

    “There is significant potential for high impact tests for sepsis and sepsis-adjacent conditions.”

    David Persing
    Head of Research and Development, Cepheid

  • Elizabeth Fowler

    In Therapeutics Development

    “[A diagnostic] could increase the probability of [trial] success as well as time saving, cost effectiveness, and limiting unnecessary patient drug exposure.”

    Valérie Raymond-Schwartzmann
    Companion Diagnostics Senior Program Director, bioMerieux

  • Dolores BigFoot

    In Antimicrobial Stewardship

    “What is diagnostic stewardship? It’s guidance and interventions to improve the appropriate use of diagnostics to guide therapeutic decisions … from test ordering, getting the right specimens, doing the testing, and ultimately reporting and communicating the results.”

    Carey-Ann Burnham
    Chief Clinical Officer, Pattern Bioscience

Challenges for Diagnostic Development and Use

Important strides in rapid diagnostic development and use were made during the ongoing COVID-19 pandemic, but significant gaps remain (Greninger, Rodriguez). Developers face challenges that may include limitations in manufacturing capacity, a lack of regulatory harmonization, market uncertainties, growing complexity of resistance mechanisms, and a lack of clinical guidelines (Persing, Rodriguez, Roth). Lessons learned during the pandemic on the part of the broader diagnostic development industry could be applied towards the development of tools to detect antimicrobial resistance (Greninger, Rodriguez).

KEY POINTS

  • Innovation in antimicrobial resistance diagnostics should center on the needs of patients and the realities of where they present for care; the COVID-19 pandemic has demonstrated that an infusion of resources and political will can lead to improvement in testing capacity. (Rodriguez)
  • There are trade-offs to consider across the different approaches for antibiotic resistance and susceptibility testing. (Whiteford)
  • As the number of analyses to diagnose antimicrobial susceptibility mount, reimbursement cannot keep pace, nor does scale necessarily add value. To keep costs down, however, the government can play an important role to ensure that bacterial panels to validate targets are readily available. (Greninger)
  • Lengthy and unpredictable pathways for coverage, coding, and payment for rapid diagnostics are barriers to the development and uptake of these products for testing antibiotic resistance and susceptibility. (Van Meter)
  • Kevin Outterson

    On Reimbursement and Market Challenges

    “There’s a mismatch between what we want, which is great diagnostics … and the way the financial incentives line up.”

    Kevin Outterson
    Professor of Law, Boston University, and Executive Director, CARB-X

  • Alex Greninger

    On Reimbursement and Market Challenges

    “[How we reimburse and pay for diagnostic tests] is the fundamental issue. Many of these multiplex tests and rapid tests are now becoming the highest cost in the clinical microbiology laboratory across all the various things that we do.”

    Alex Greninger
    Assistant Professor, and Assistant Director, Clinical Virology Laboratories, University of Washington Medical Center

  • Gregory Frank

    On Reimbursement and Market Challenges

    “When you go through the regulatory process for approval…there are no opportunities for reimbursement considerations for updated susceptibility tests that come to market.”

    Gregory Frank
    Director, Global Public Policy, Merck

  • John Billington

    On Reimbursement and Market Challenges

    “We need to identify some policy opportunities or incentives to correct the market inefficiencies [for diagnostics].”

    John Billington
    Head of Commercial Pipeline and Health Security Policy and Advocacy, GSK

  • Anthony So

    On Access and Ethical Considerations

    “The mismatch between innovation and access to AMR diagnostics could not be more stark than in the resource-limited settings of low- and middle-income countries.”

    Anthony So
    Professor of the Practice, and Director, Innovation + Design Enabling Access (IDEA) Initiative, Johns Hopkins Bloomberg School of Public Health

  • Nicholas Evans

    On Access and Ethical Considerations

    “Diagnostics that are unaffordable globally are a waste of resources, because we cannot treat a global problem if not everyone can get access to these diagnostics.”

    Nicholas Evans
    Chair of the University of Massachusetts Lowell Department of Philosophy, Associate Professor, University of Massachusetts Lowell

  • William Rodriguez

    On Access and Ethical Considerations

    “Patients present for care around the world in very specific circumstances, and our tests have to meet patients where they are.”

    William “Bill” Rodriguez
    Chief Executive Officer, FIND

  • Tracy L. Cohen

    On Access and Ethical Considerations

    “Diagnostics must be justly distributed and financially accessible in conformity with the principle of social justice.”

    Tracy L. Cohen
    Distinguished Visiting Scholar, Institute for Bioethics & Health Policy, University of Miami Miller School of Medicine

Considering a Path Forward

Antibiotic resistance is complex—it involves a diversity of bacterial species, multiple clinical syndromes, and a variety of care settings, so there will likewise be more than one diagnostic-based solution (J. Patel, Van Meter). There is a need to mobilize people, organizations, and the public to engage on the issue of diagnosis and treatment and take action (Kester, Shawar, Trainor).

KEY POINTS

  • Traditional tests for antibiotic resistance or susceptibility are slow, but emerging innovations hold promise for rapid point-of-care testing. (Carroll)
  • Market forces alone may not be sufficient to drive the development of diagnostics and therapeutics; the government has an important role to play in supporting innovations in this area. (Sciarretta)
  • There are resources and support available through the National Institute of Allergy and Infectious Diseases for the development of diagnostics. (Eder)
  • The Food and Drug Administration responded to the COVID-19 pandemic with increased flexibility and streamlined processes; these changes may be beneficial for addressing drug-resistant infections more broadly. (Roth)
  • Given the complexity of diagnostic technologies and drug-resistance mechanisms, public–private partnerships are critical for development and regulatory approval of innovations. (Persing)
  • Jean Patel

    On Workforce to Support Optimal Use

    “Microbiology lab staff has been decimated because of COVID-19. There is a need to replenish that staff. We cannot go on with diminished technical expertise in infectious disease diagnostics.”

    Jean Patel
    Principal Scientific Affairs, Microbiology, Beckman Coulter Diagnostics

  • Joseph Lutgring

    On Workforce to Support Optimal Use

    “As testing strategies become more complex and as more diagnostics become available, it will be crucial that clinicians are educated and provided with assistance [in] understanding how these results should be interpreted to best care for their patients.”

    Joseph Lutgring
    Medical Officer, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention

  • Diane Flayhart

    On Workforce to Support Optimal Use

    “We need to use the tests we have available today more effectively. And we can do that through … promoting better guidelines and protocols.”

    Diane Flayhart
    Global Program Leader, Becton, Dickinson and Company

  • Joseph Larsen

    On Policy Paths Forward

    “Policy-based reform to the way [diagnostics] are reimbursed would be an appropriate first step to increase adoption.”

    Joseph Larsen
    Vice President, Clinical Development, Locus Biosciences, Inc.

  • Ritu Banerjee

    On Policy Paths Forward

    “Federal legislation that mandates stewardship program … would go a long way toward supporting uptake, appropriate use, appropriate implementation, and interpretation of diagnostics.”

    Ritu Banerjee
    Medical Director, Pediatric Antimicrobial Stewardship Program, Vanderbilt University

  • Robin Patel

    On Policy Paths Forward

    “We have to recognize that we’re not using antibiotics as well as we could in health care, and that we can make that situation better with improved diagnostics.”

    Robin Patel
    Elizabeth P. and Robert E. Allen Professor of Individualized Medicine, ID Physician, Clinical Microbiology Laboratory Director, Mayo Clinic

  • Shader Smith

    On Policy Paths Forward

    “There’s so much that can be learned from the voices and experiences of people living with and dying from AMR - more so than from the details of a particular strain of bacteria. These experiences are as diverse as they are misunderstood.”

    Diane Shader Smith
    mother of the late Mallory Smith, author of Salt in My Soul: An Unfinished Life, and antimicrobial resistance advocate

Learn More

cover

To watch the workshop, click on the following links to each session:

1 This page is a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants. These views are not necessarily endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as reflecting any group consensus.

SHARE THIS PAGE