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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Page xiii Cite
Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18495.
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Technologies to Enable Autonomous Detection for BioWatch Ensuring Timely and Accurate Information for Public Health Officials WORKSHOP SUMMARY India Hook-Barnard, Sheena M. Posey Norris, and Joe Alper, Rapporteurs Board on Health Sciences Policy Board on Life Sciences

THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, NW • Washington, DC 20001 NOTICE: The workshop that is the subject of this workshop summary was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. This activity was supported by Contract No. HSHQDC-12-J-00188 between the National Academy of Sciences and the Department of Homeland Security, Office of Health Affairs. The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the activity. International Standard Book Number-13: 978-0-309-29251-1 International Standard Book Number-10: 0-309-29251-4 Additional copies of this workshop summary are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624- 6242 or (202) 334-3313; http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2014 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: IOM (Institute of Medicine) and NRC (National Research Council). 2014. Technologies to enable autonomous detection for BioWatch: Ensuring timely and accurate information for public health officials: Workshop summary. Washington, DC: The National Academies Press.

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. C. D. Mote, Jr., is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. C. D. Mote, Jr., are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

PLANNING COMMITTEE FOR A WORKSHOP ON STRATEGIES FOR COST-EFFECTIVE AND FLEXIBLE BIODETECTION SYSTEMS THAT ENSURE TIMELY AND ACCURATE INFORMATION FOR PUBLIC HEALTH OFFICIALS1 WILLIAM RAUB (Chair), Science Advisor to the Secretary, Department of Health and Human Services (Retired) RITA COLWELL, Distinguished University Professor, University of Maryland; Professor, Johns Hopkins University Bloomberg School of Public Health JEFFREY DUCHIN, Chief, Communicable Disease Epidemiology and Immunization Section, Public Health–Seattle & King County; Professor in Medicine, Division of Allergy and Infectious Diseases, University of Washington School of Medicine SUZET M. MCKINNEY, Deputy Commissioner, Bureau of Public Health Preparedness and Emergency Response; Division of Women and Children’s Health, Chicago Department of Public Health BETH MALDIN MORGENTHAU, Assistant Commissioner, Bureau of Policy, Community Resilience and Response, Office of Emergency Preparedness and Response, New York City Department of Health and Mental Hygiene DONALD PROSNITZ, Independent Consultant JOHN VITKO, Rector, St. Luke Church, Department of Homeland Security (Retired) IOM/NRC Staff INDIA HOOK-BARNARD, Senior Program Officer BRUCE M. ALTEVOGT, Senior Program Officer SHEENA M. POSEY NORRIS, Research Associate RACHEL KIRKLAND, Senior Program Assistant ANDREW M. POPE, Director, Board on Health Sciences Policy FRANCES E. SHARPLES, Director, Board on Life Sciences 1 Institute of Medicine/National Research Council planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. v

BOARD ON HEALTH SCIENCES POLICY1 C. THOMAS CASKEY (Chair), Baylor College of Medicine ELI Y. ADASHI, Brown University WYLIE BURKE, University of Washington ROBERT M. CALIFF, Duke University Medical Center DENNIS CHOI, Stony Brook University KATHLEEN A. DRACUP, University of California, San Francisco MICHAEL EHLERS, Pfizer Inc. NAOMI L. GERBER, George Mason University LEWIS R. GOLDFRANK, Bellevue Hospital Center and New York University Langone Medical Center STEVEN E. HYMAN, Broad Institute of Harvard University and Massachusetts Institute of Technology PAUL E. JARRIS, Association of State and Territorial Health Officials JEFFREY KAHN, Johns Hopkins University HARRY T. ORR, University of Minnesota SHARON TERRY, Genetic Alliance REED V. TUCKSON, Tuckson Health Connections, LLC KEITH A. WAILOO, Princeton University CLYDE YANCY, Feinberg School of Medicine and Northwestern Memorial Hospital IOM Staff ANDREW M. POPE, Director DONNA RANDALL, Administrative Assistant 1 Institute of Medicine boards do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. vii

BOARD ON LIFE SCIENCES1 JO HANDELSMAN (Chair), Yale University SEAN EDDY, Howard Hughes Medical Institute, Janelia Farm Research Campus SARAH C. R. ELGIN, Washington University DAVID R. FRANZ, Former Commander, U.S. Army Medical Research Institute for Infection Diseases, Consultant LOUIS J. GROSS, University of Tennessee RICHARD A. JOHNSON, Arnold & Porter, LLC JUDITH KIMBLE, University of Wisconsin–Madison CATO T. LAURENCIN, University of Connecticut Health Center ALAN I. LESHNER, American Association for the Advancement of Science KAREN E. NELSON, J. Craig Venter Institute ROBERT M. NEREM, Georgia Institute of Technology CAMILLE PARMESAN, University of Texas ALISON G. POWER, Cornell University MARGARET RILEY, University of Massachusetts, Amherst JANIS C. WEEKS, University of Oregon MARY WOOLLEY, Research!America NRC Staff JO L. HUSBANDS, Scholar/Senior Project Director JAY B. LABOV, Senior Scientist and Program Director for Biology Education KATHERINE W. BOWMAN, Senior Program Officer INDIA HOOK-BARNARD, Senior Program Officer MARILEE K. SHELTON-DAVENPORT, Senior Program Officer KEEGAN SAWYER, Program Officer BETHELHEM M. BANJAW, Financial Associate CARL G. ANDERSON, Program Associate SAYYEDA AYESHA AHMED, Senior Program Assistant FRANCES E. SHARPLES, Director 1 National Research Council boards do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. ix

Reviewers This workshop summary has been reviewed in draft form by individ- uals chosen for their diverse perspectives and technical expertise, in ac- cordance with procedures approved by the National Research Council’s Report Review Committees. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published workshop summary as sound as possible and to en- sure that the workshop summary meets institutional standards for objec- tivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integri- ty of the process. We wish to thank the following individuals for their review of this workshop summary: Sara Beatrice, New York City Department of Health Cindy Bruckner-Lea, Pacific Northwest National Laboratory C. Rick Lyons, Colorado State University Stephen S. Morse, Columbia University Although the reviewers listed above have provided many construc- tive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this workshop summary was overseen by Enriqueta C. Bond, Burroughs Wellcome Fund. Appointed by the Institute of Medicine, she was responsible for making certain that an independent examination of this workshop sum- mary was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this workshop summary rests entirely with the rappor- teurs and the institution. xi

Contents ACRONYMS AND ABBREVIATIONS xv 1 INTRODUCTION 1 2 OVERVIEW OF THE BIOWATCH PROGRAM 7 3 PUBLIC HEALTH’S PERSPECTIVE ON THE ROLE OF BIOWATCH IN THE DECISION-MAKING PROCESS 23 4 POTENTIAL TECHNOLOGIES FOR THE BIOWATCH PROGRAM 41 5 FINAL THOUGHTS 81 APPENDIXES A References 95 B Biographical Sketches of Workshop Participants 99 C Workshop Agenda 123 D Registered Attendees 135 E Technology Readiness Levels in the Department of Defense 141 F White Paper 1: The BioWatch Program: What Information Is Needed to Inform Decision Making? 145 xiii

xiv CONTENTS G White Paper 2: Nucleic-Acid Signatures at Three Levels of Readiness for BioWatch 155 H White Paper 3: State of the Art for Autonomous Detection Systems Using Immunoassays and Protein Signatures 173 I White Paper 4: State of the Art for Autonomous Detection Systems Using Genomic Sequencing 197 J White Paper 5: State of the Art for Autonomous Detection Systems Using Mass Spectrometry 215

Acronyms and Abbreviations APDS autonomous pathogen detection system BAC BioWatch Advisory Committee BAR BioWatch Actionable Result BDS biohazard detection system CB chemical biological CDC Centers for Disease Control and Prevention Ct cycle threshold CTA Chicago Transit Authority DHS Department of Homeland Security DoD Department of Defense EPA Environmental Protection Agency FBI Federal Bureau of Investigation FDA Food and Drug Administration HHS Department of Health and Human Services HSMS Hamilton Sundstrand CB mass spectrometer IOM Institute of Medicine LANL Los Alamos National Laboratory LLNL Lawrence Livermore National Laboratory xv

xvi ACRONYMS AND ABBREVIATIONS MALDI matrix-assisted laser desorption/ionization M-BAND microfluidic bioagent autonomous networked detector MS mass spectroscopy NG-ADS next-generation automated detection system NGS next-generation sequencing NHGRI National Human Genome Research Institute NORAD North American Aerospace Defense Command NRC National Research Council OHA Office of Health Affairs (DHS) PCR polymerase chain reaction PSU portable sensor unit REBS resource effective bio-identification system SPAMS single-particle aerosol mass spectrometer TRL technology readiness level USPS U.S. Postal Service

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The BioWatch program, funded and overseen by the Department of Homeland Security (DHS), has three main elements—sampling, analysis, and response—each coordinated by different agencies. The Environmental Protection Agency maintains the sampling component, the sensors that collect airborne particles. The Centers for Disease Control and Prevention coordinates analysis and laboratory testing of the samples, though testing is actually carried out in state and local public health laboratories. Local jurisdictions are responsible for the public health response to positive findings. The Federal Bureau of Investigation is designated as the lead agency for the law enforcement response if a bioterrorism event is detected. In 2003 DHS deployed the first generation of BioWatch air samplers. The current version of this technology, referred to as Generation 2.0, requires daily manual collection and testing of air filters from each monitor. DHS has also considered newer automated technologies (Generation 2.5 and Generation 3.0) which have the potential to produce results more quickly, at a lower cost, and for a greater number of threat agents.

Technologies to Enable Autonomous Detection for BioWatch is the summary of a workshop hosted jointly by the Institute of Medicine and the National Research Council in June 2013 to explore alternative cost-effective systems that would meet the requirements for a BioWatch Generation 3.0 autonomous detection system, or autonomous detector, for aerosolized agents . The workshop discussions and presentations focused on examination of the use of four classes of technologies—nucleic acid signatures, protein signatures, genomic sequencing, and mass spectrometry—that could reach Technology Readiness Level (TRL) 6-plus in which the technology has been validated and is ready to be tested in a relevant environment over three different tiers of temporal timeframes: those technologies that could be TRL 6-plus ready as part of an integrated system by 2016, those that are likely to be ready in the period 2016 to 2020, and those are not likely to be ready until after 2020. Technologies to Enable Autonomous Detection for BioWatch discusses the history of the BioWatch program, the role of public health officials and laboratorians in the interpretation of BioWatch data and the information that is needed from a system for effective decision making, and the current state of the art of four families of technology for the BioWatch program. This report explores how the technologies discussed might be strategically combined or deployed to optimize their contributions to an effective environmental detection capability.

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