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

      INSTITUTE OF MEDICINE AND    
NATIONAL RESEARCH COUNCIL
              OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

www.nap.edu



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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

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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.

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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

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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

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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

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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

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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

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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

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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

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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

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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