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Better Tests, Better Care: Improved Diagnostics for Infectious Diseases

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Better Tests, Better Care: Improved Diagnostics for Infectious Diseases IDSA PUBLIC POLICY Better Tests, Better Care: Improved Diagnostics for Infectious Diseases Angela M. Caliendo,1 David N. Gilbert,2,3 Christine C. Ginocchio,4,5,6 Kimberly E. Hanson,7,8 Larissa May,9 Thomas C. Quinn,10,11 Fred C. Tenover,12 David Alland,13 Anne J. Blaschke,14 Robert A. Bonomo,15,16,17,18 Karen C. Carroll,19,20 Mary Jane Ferraro,21,22 Lisa R. Hirschhorn,23,24 W. Patrick Joseph,25,26,27,28 Tobi Karchmer,29 Ann T. MacIntyre,30,31 L. Barth Reller,32,33 and Audrey F. Jackson;34 for the Infectious Diseases Society of America (IDSA) 1Department of Medicine, Alpert Medical School of Brown University, Providence, Rhode Island; 2Division of Infectious Diseases, Providence Portland Medical Center, and 3Department of Medicine, Oregon Health & Science University, Portland, Oregon; 4Division of Infectious Disease Diagnostics, North Shore–LIJ Laboratories, Lake Success, and Departments of 5Pathology and Laboratory Medicine and 6Molecular Medicine, Hofstra North Shore–LIJ School of Medicine, Hempstead, New York; Departments of 7Medicine and 8Pathology, University of Utah, Salt Lake City; 9Department of Emergency Medicine, George Washington University, Washington, District of Columbia; 10Division of Intramural Research, National Institute of Allergy and 11 Infectious Diseases, National Institutes of Health, Bethesda, and Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland; Downloaded from 12Cepheid, Sunnyvale, California; 13Center for Emerging Pathogens, Department of Medicine, Rutgers–New Jersey Medical School, Rutgers University, Newark; 14Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City; 15Research Service, Louis Stokes Cleveland Department of Veterans Affairs Medical Center, and Departments of 16Medicine, 17Pharmacology, and 18Molecular Biology and Microbiology, Case Western Reserve University School of Medicine, Cleveland, Ohio; 19Department of Pathology, Division of Medical Microbiology, and 20Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland; Departments of 21 22 23 Pathology and Medicine, Harvard Medical School and Massachusetts General Hospital, Department of Global Health and Social Medicine, Harvard http://cid.oxfordjournals.org/ Medical School, and 24JSI Research and Training Institute, Boston, Massachusetts; 25Siemens Clinical Laboratory, Berkeley, 26Genomic Health, Redwood City, 27XDx Laboratory, San Francisco, and 28Tethys Bioscience, Emeryville, California; 29Becton, Dickinson and Company, Sparks, Maryland; 30Infectious Diseases, Private Practice, Miami, and 31Department of Internal Medicine, Nova Southeastern University, Fort Lauderdale, Florida; Departments of 32Medicine and 33Pathology, Duke University School of Medicine, Durham, North Carolina; and 34Infectious Diseases Society of America, Arlington, Virginia In this IDSA policy paper, we review the current diagnostic landscape, including unmet needs and emerging technologies, and assess the challenges to the development and clinical integration of improved tests. To fulfill fi the promise of emerging diagnostics, IDSA presents recommendations that address a host of identi ed barri- at IDSA on July 7, 2014 ers. Achieving these goals will require the engagement and coordination of a number of stakeholders, including Congress, funding and regulatory bodies, public health agencies, the diagnostics industry, healthcare systems, professional societies, and individual clinicians. Keywords. diagnostics; rapid diagnostics; point-of-care testing; molecular diagnostics; clinical microbiology; infectious diseases EXECUTIVE SUMMARY The Infectious Diseases Society of America (IDSA) is a national medical society representing infectious diseases physicians, scientists, and other healthcare profes- sionals dedicated to promoting health through excellence in infectious diseases re- Whether caring for an individual patient with an infec- search, education, prevention, and patient care. The Society, which has >10 000 tious disease or responding to a worldwide pandemic, members, was founded in 1963 and is based in Arlington, Virginia. (For more infor- mation, visit www.idsociety.org.) This policy paper was developed for and approved the rapid and accurate establishment of a microbial by the IDSA Board of Directors on 20 August 2013. cause is fundamental to quality care. Despite dramatic Correspondence: Audrey F. Jackson, PhD, Infectious Diseases Society of America, advances in diagnostic technologies, many patients 1300 Wilson Blvd, Ste 300, Arlington, VA 22209 ([email protected]). Clinical Infectious Diseases 2013;57(S3):S139–70 with suspected infections receive empiric antimicrobial © The Author 2013. Published by Oxford University Press on behalf of the Infectious therapy rather than appropriate therapy dictated by the Diseases Society of America. All rights reserved. For Permissions, please e-mail: fi [email protected]. rapid identi cation of the infectious agent. The result is DOI: 10.1093/cid/cit578 overuse of our small inventoryof effective antimicrobials, Improved Infectious Diseases Diagnostics • CID 2013:57 (Suppl 3) • S139 whose numbers continue to dwindle due to increasing levels of (b) NIH should ensure that the peer review process for antimicrobial resistance. diagnostics grant submissions includes study sections with New tests are needed that can identify a specificpathogenor appropriate expertise to evaluate feasibility and clinical at a minimum, distinguish between bacterial and viral infections, applicability, as well as scientific merit. and also provide information on susceptibility to antimicrobial (c) Biorepositories or other infrastructure to facilitate agents. Tests should be easy to use and provide a rapid result the procurement of critical clinical specimens should be (ideally within an hour) to have a positive impact on care. developed and maintained to aid in the validation and Results must be effectively communicated to the healthcare pro- verification of novel diagnostic methods (see Appendix B vider or public health practitioner and may require the interpre- for a model of how a repository could work). tive expertise of an infectious diseases physician or clinical 2. Because of the impact on patient care, public health sur- microbiologist. The infectious diseases physician can serve as a veillance, and biodefense, Congress should support increased bridge between the laboratory and the healthcare provider to appropriations for diagnostics activities, including to: ensure the proper use and interpretation of diagnostic testing. The expertise of the infectious diseases clinician becomes more (a) NIH, including the SBIR diagnostics program at the important with the advent of newer, more complex tests. The National Institute of Allergy and Infectious Diseases availability of needed tests will lead to improvements in clinical (NIAID) and the Point-of-Care Technologies Research outcomes for patients, antimicrobial stewardship, detection and Network at the National Institute of Biomedical Imaging tracking of disease outbreaks, and investigation of unknown and Bioengineering; pathogens, both in the United States and globally. (b) The Biomedical Advanced Research and Develop- Downloaded from Emerging technologies enable the detection and quantification ment Authority for the advanced development of innova- of pathogen burden with new speed, sensitivity, and simplicity of tive infectious diseases diagnostics; and use. However, there are significant challenges to the develop- (c) The Centers for Disease Control and Prevention ment, regulatory approval, and clinical integration of diagnostic (CDC) for the Advanced Molecular Detection (AMD) ini- http://cid.oxfordjournals.org/ tests that use these new technologies. The need for diagnostics tiative, designed to acquire updated technologies for public that advance clinical care and public health has never been health surveillance. greater, and there is a critical window of opportunity to harness 3. Because of the need to accelerate specific areas of diagnos- new technologies to address the greatest unmet needs. tics development, such as rapid diagnostics and diagnostics for In this Infectious Diseases Society of America (IDSA) policy resource-limited settings, Congress should enact: paper, we review the current diagnostic landscape, including unmet needs and emerging technologies, and assess the chal- (a) Legislation in support of a tax credit to cover 50% at IDSA on July 7, 2014 lenges to the development and clinical integration of improved of clinical research costs for qualifying rapid diagnostics; tests. To fulfill the promise of emerging diagnostics, IDSA pre- and sents recommendations that address a host of identified barri- (b) The 21st Century Global Health Technology Act (H. ers. Achieving these goals will require the engagement and R. 1515), which will strengthen health R&D programs at coordination of a number of stakeholders, including Congress, the United States Agency for International Development funding and regulatory bodies, public health agencies, the diag- (USAID) and require no new funding. nostics industry, healthcare systems, professional societies, and 4. To address the highest priority unmet needs, federal in- individual clinicians. centives to stimulate diagnostics R&D should focus on tests with the following characteristics: RECOMMENDATIONS (a) Performed directly from accessible, minimally inva- sive clinical
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