STATE-OF-THE-ART REVIEW Point-of-Care Technologies for Precision Cardiovascular Care and Clinical Research National Heart, Lung, and Blood Institute Working Group Kevin R. King, MD, PHD, a,b Luanda P. Grazette, MD, MPH, c Dina N. Paltoo, PHD, MPH, d John T. McDevitt, PHD, e Samuel K. Sia, PHD, f Paddy M. Barrett, MD, g Fred S. Apple, PHD, h Paul A. Gurbel, MD, i Ralph Weissleder, MD, PHD, b Hilary Leeds, JD, d Erin J. Iturriaga, MSN, j Anupama K. Rao, MD, j Bishow Adhikari, PHD, j Patrice Desvigne-Nickens, MD, j Zorina S. Galis, PHD, j Peter Libby, MD a SUMMARY Point-of-care technologies (POC or POCT) are enabling innovative cardiovascular diagnostics that promise to improve patient care across diverse clinical settings. The National Heart, Lung, and Blood Institute convened a working group to discuss POCT in cardiovascular medicine. The multidisciplinary working group, which included clinicians, scientists, engi- neers, device manufacturers, regulatory officials, and program staff, reviewed the state of the POCT field; discussed op- portunities for POCT to improve cardiovascular care, realize the promise of precision medicine, and advance the clinical research enterprise; and identified barriers facing translation and integration of POCT with existing clinical systems. A POCT development roadmap emerged to guide multidisciplinary teams of biomarker scientists, technologists, health care pro- viders, and clinical trialists as they: 1) formulate needs assessments; 2) define device design specifications; 3) develop component technologies and integrated systems; 4) perform iterative pilot testing; and 5) conduct rigorous prospective clinical testing to ensure that POCT solutions have substantial effects on cardiovascular care. (J Am Coll Cardiol Basic Trans Sci 2016;1:73–86) © 2016 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). From the a Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, Massachusetts; b Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; c Division of Cardiovascular Medicine, University of Southern California, Los Angeles, California; d Office of Science Policy, Office of the Director, National Institutes of Health, Bethesda, Maryland; e Depart- ments of Bioengineering and Chemistry, Rice University, Houston, Texas; f Department of Biomedical Engineering, Columbia University, New York, New York; g Scripps Translational Science Institute, La Jolla, California; h Hennepin County Medical Center and University of Minnesota, Department of Laboratory Medicine and Pathology, Minneapolis, Minnesota; i Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Falls Church, Virginia; and the j National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. Support for the Working Group was provided by the Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health (NIH). Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Heart, Lung, and Blood Institute or the National Institutes of Health. Dr. King has received the following grants: AHA 15MCPRP25690031, NIH-NHLBI 1K99HL129168, and Harvard Medical School LaDue Memorial Fellowship. Ms. Leeds, Ms. Iturriaga, and Drs. Paltoo, Rao, Adhikari, Desvigne-Nickens, and Galis are employees of the NIH. Dr. Grazette is a consultant for St. Jude, Amgen, and Relypsa; is an investigator for Novartis; and is a contractor for St. Jude. Dr. McDevitt serves as the scientific founder and has financial interests in LabNow and Force Diagnostics; and owns stock in SensoDx. Dr. Sia is a cofounder of Claros Diagnostics, acquired by OPKO Health. Dr. Barrett has received grant support from the U.S. NIH National Center for Advancing Translational Sciences (NCATS) grant (KL2TR000112). Dr. Apple has received grant support (nonsalaried) through the Minneapolis Medical Research Foundation, Abbott Diagnostics, Siemens, Ortho-Clinical Diagnostics, Roche Diagnostics, Radi- ometer, BRAHMS, Genentech, Arkray, BioMerieux, Alere, and Beckman Coulter; has been a paid consultant (<$10,000) for Instrumentation Laboratory T2 Biosystems and Philips Healthcare Incubator; and has served on the scientific advisory boards of Alere, Beckman Coulter, Instrumentation Laboratory, and Abbott Diagnostics. Dr. Gurbel has been a consultant for Daiichi Sankyo, Bayer, AstraZeneca, Boehringer Ingelheim, Merck, Medtronic, CSL, and Haemonetics; has received grant support from the NIH, Daiichi Sankyo, CSL, AstraZeneca, Coramed, Haemonetics, Medtronic, Harvard Clinical Research Institute, and Duke Clinical JACC: BASIC TO TRANSLATIONAL SCIENCE VOL. 1, NO. 1-2, 2016 ª 2016 THE AUTHORS. PUBLISHED BY ELSEVIER ON BEHALF OF THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION. THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY-NC-ND LICENSE ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ). ISSN 2452-302X http://dx.doi.org/10.1016/j.jacbts.2016.01.008