Opportunities and Challenges for the Development and Adoption of Multicancer Detection Tests
Convened October 28–29, 2024
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Francis Amankwah, Anne Johnson, and Sharyl Nass, Rapporteurs
National Cancer Policy Forum
Board on Health Care Services
Health and Medicine Division
Proceedings of a Workshop
NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
This activity was supported by Contract No. 75D30121D11240 (Task Order No. 75D30124F00042) and Contract No. 75N98024D00037 (Task Order No. 75N98025F00002) with the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health, respectively, and by the American Association for Cancer Research, American Cancer Society, American College of Radiology, American Society of Clinical Oncology, Association of American Cancer Institutes, Association of Cancer Care Centers, Cancer Center at Illinois, Flatiron Health, Merck, National Comprehensive Cancer Network, Novartis Oncology, Oncology Nursing Society, Partners In Health, Patient Advocate Foundation, and Pfizer Inc. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
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Digital Object Identifier: https://doi.org/10.17226/29114
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2025. Opportunities and challenges for the development and adoption of multicancer detection tests: Proceedings of a workshop. Washington, DC: National Academies Press. https://doi.org/10.17226/29114.
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WORKSHOP PLANNING COMMITTEE
BETH Y. KARLAN (Co-Chair), University of California, Los Angeles
LAWRENCE N. SHULMAN (Co-Chair), University of Pennsylvania
JUSTIN E. BEKELMAN, Daymark Health
PHILIP E. CASTLE, National Institutes of Health
RUTH ETZIONI, Fred Hutchinson Cancer Center
CHANITA HUGHES-HALBERT, University of Southern California
ELENA MARTÍNEZ, University of California, San Diego
ETTA PISANO, American College of Radiology
ROBERT A. WINN, Virginia Commonwealth University
Project Staff
ANNA ADLER, Senior Program Assistant (until November 2024)
TORRIE BROWN, Program Coordinator
MAKEDA HAUGHTON, Senior Program Assistant (from December 2024)
EMMA WICKLAND, Research Associate
JULIE WILTSHIRE, Senior Finance Business Partner
JENNIFER ZHU, Associate Program Officer
ERIN BALOGH, Co-Director, National Cancer Policy Forum (until June 2024)
FRANCIS AMANKWAH, Co-Director, National Cancer Policy Forum (from July 2024)
SHARYL NASS, Co-Director, National Cancer Policy Forum; Senior Director, Board on Health Care Services
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NATIONAL CANCER POLICY FORUM1
ROBERT A. WINN (Chair), Virginia Commonwealth University
ROHIT BHARGAVA, Cancer Center at Illinois
SMITA BHATIA, The University of Alabama at Birmingham
GIDEON BLUMENTHAL, Merck
CHRIS BOSHOFF, Pfizer Inc.
CHRISTINA CHAPMAN, Baylor College of Medicine; Michael E. DeBakey VA Medical Center
GWEN DARIEN, Patient Advocate Foundation
CRYSTAL DENLINGER, National Comprehensive Cancer Network
JAMES H. DOROSHOW, National Institutes of Health
S. GAIL ECKHARDT, Baylor College of Medicine
CHRISTOPHER R. FRIESE, University of Michigan
SCARLETT LIN GOMEZ, University of California, San Francisco
JULIE R. GRALOW, American Society of Clinical Oncology
SARAH GREENE, Independent Consultant; Patient Advocate
ROY S. HERBST, Yale University; American Association for Cancer Research
HEDVIG HRICAK, Memorial Sloan Kettering Cancer Center
CHANITA HUGHES-HALBERT, University of Southern California
ROY A. JENSEN, University of Kansas; Association of American Cancer Institutes
RANDY A. JONES, University of Virginia
BETH Y. KARLAN, University of California, Los Angeles
NANCY KEATING, Harvard Medical School
SAMIR N. KHLEIF, Georgetown University; Society for Immunotherapy of Cancer
RONALD M. KLINE, Centers for Medicare & Medicaid Services
SHIVAANI KUMMAR, Oregon Health & Science University
ELENA MARTÍNEZ, University of California, San Diego
LARISSA NEKHLYUDOV, Brigham and Women’s Hospital; Dana-Farber Cancer Institute; Harvard Medical School
CLEO A. RYALS, Flatiron Health
JULIE SCHNEIDER, Oncology Center of Excellence, U.S. Food and Drug Administration
SUSAN M. SCHNEIDER, Duke University
LAWRENCE N. SHULMAN, University of Pennsylvania
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1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
HEIDI SMITH, Novartis Pharmaceuticals
AMYE J. TEVAARWERK, Mayo Clinic
KATRINA TRIVERS, Centers for Disease Control and Prevention
ROBIN YABROFF, American Cancer Society
Forum Staff
TORRIE BROWN, Program Coordinator
MAKEDA HAUGHTON, Senior Program Assistant
EMMA WICKLAND, Research Associate (through May 2025)
JULIE WILTSHIRE, Senior Finance Business Partner
JENNIFER ZHU, Associate Program Officer
FRANCIS AMANKWAH, Co-Director, National Cancer Policy Forum
SHARYL NASS, Co-Director, National Cancer Policy Forum; Senior Director, Board on Health Care Services
Reviewers
This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their technical expertise and perspectives. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.
We thank the following individuals for their review of this proceedings:
RONALD E. MYERS, Thomas Jefferson University
NOEL S. WEISS, University of Washington
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by DANIEL MASYS, University of Washington. He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.
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Acknowledgments
The National Cancer Policy Forum is grateful for the support of our many annual sponsors. Federal sponsors include the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health. Nonfederal sponsors include the American Association for Cancer Research, American Cancer Society, American College of Radiology, American Society of Clinical Oncology, Association of American Cancer Institutes, Association of Cancer Care Centers, Cancer Center at Illinois, Flatiron Health, Merck, National Comprehensive Cancer Network, Novartis Oncology, Oncology Nursing Society, Partners In Health, Patient Advocate Foundation, and Pfizer Inc.
The forum wishes to express its gratitude to the expert speakers whose presentations and discussions helped inform the research and development of multicancer detection tests and promote policies aimed at the implementation of effective multicancer detection tests to improve outcomes for all patients. The forum also wishes to thank the members of the planning committee for their work in developing an excellent workshop agenda.
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Contents
EXAMINING OPPORTUNITIES AND CHALLENGES OF MULTICANCER DETECTION TESTS IN CANCER CARE
Cancer Screening for Early Detection
Multicancer Detection Tests Approaches
Potential Benefits of Multicancer Detection Tests
Challenges and Potential Pitfalls of Multicancer Detection Tests
MULTICANCER DETECTION TESTS: FROM PERFORMANCE TO OUTCOMES
Understanding Multicancer Detection Test Performance
Clinical Trial Design and End Point Selection
Challenges in Conducting Clinical Trials When Multicancer Detection Tests Are Commercially Available
Modeling Approaches and Applications
CONSIDERATIONS FOR IMPLEMENTING MULTICANCER DETECTION TESTS IN THE CANCER CARE CONTINUUM
Perspectives on Multicancer Detection Tests in Different Clinical Contexts
Addressing Multicancer Detection Tests in Care Pathways and Guidelines
Strategies for Ensuring Appropriate Communication and Follow-Up
HEALTH SYSTEM, ECONOMIC, AND POLICY CONSIDERATIONS
Health Equity Considerations to Overcome Challenges Facing Different Populations
Health Economic Considerations
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Acronyms and Abbreviations
| ACS | American Cancer Society |
| AI | artificial intelligence |
| cfDNA | cell-free DNA |
| CLIA | Clinical Laboratory Improvement Amendments |
| FDA | U.S. Food and Drug Administration |
| LDT | laboratory-developed test |
| MCD | multicancer detection |
| NCI | National Cancer Institute |
| PPV | positive predictive value |
| RCT | randomized controlled trial |
| UHG | UnitedHealth Group |
| USPSTF | United States Preventive Services Task Force |
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