Exploring the Case for a Global Alliance for Medical Diagnostics Initiative.

diagnostics Review Exploring the Case for a Global Alliance for Medical Diagnostics Initiative Melissa L. Mugambi 1 , Kara M. Palamountain 2 , Jim Gallarda 3 and Paul K. Drain 4,5,6,7, * 1 2 3 4 5 6 7 * Department of Global Health, University of Washington, Seattle, WA 98195, USA; Kellogg School of Management, Northwestern University, Evanston, IL 60208, USA; Bill and Melinda Gates Foundation, Seattle, WA 98109, USA; International Clinical Research Center, Department of Global Health, University of Washington, Seattle, WA 98195, USA Division of Infectious Diseases, Department of Medicine, University of Washington, Seattle, WA 98195, USA Department of Epidemiology, University of Washington, Seattle, WA 98195, USA Department of Surgery, Massachusetts General Hospital, Boston, MA 02114, USA Correspondence: ; Tel.: +1-206-520-3820; Fax: +1-206-520-3831 Academic Editor: Sandeep Kumar Vashist Received: 14 December 2016; Accepted: 22 January 2017; Published: 26 January 2017 Abstract: In recent years, the private and public sectors have increased investments in medical diagnostics for low- and middle-income countries (LMICs). Despite these investments, numerous barriers prevent the adoption of existing diagnostics and discourage the development and introduction of new diagnostics in LMICs. In the late 1990s, the global vaccine community had similar challenges, as vaccine coverage rates stagnated and the introduction of new vaccines was viewed as a distraction to delivering existing vaccines. To address these challenges, the international community came together and formed the Global Alliance for Vaccines Initiative (GAVI). Sixteen years after the formation of GAVI, we see evidence of a healthier global vaccine landscape. We discuss how GAVI’s four guiding principles (product, health systems strengthening, financing and market shaping) might apply to the advancement of medical diagnostics in LMICs. We present arguments for the international community and existing organizations to establish a Global Alliance for Medical Diagnostics Initiative (GAMDI). Keywords: point-of-care diagnostics; global health; low- and middle-income countries; alliance 1. Introduction In recent years, the private and public sectors have increased investments in the development of diagnostics for low- and middle-income countries (LMICs). Many of these investments have focused on human immunodeficiency virus (HIV), tuberculosis (TB), and malaria because of the concentrated burden of these diseases. These investments have also included support for developing medical diagnostic point-of-care (PoC) testing platforms, due in part to challenges posed by central laboratory systems. While centralized laboratories play an important role in providing medical diagnostic services, they require significant laboratory infrastructure and trained personnel. As patient samples are transported from a network of health facilities in urban and rural settings to centralized laboratories, delays in testing may result in patient loss to follow-up or poor retention in care [1,2]. Decentralized PoC technologies might address the challenges associated with centralized laboratory testing, provided they are easy-to-use, cost effective, provide results within a reasonable time, and yield better patient outcomes [3]. PoC tests continue to supplement, not replace, centralized laboratory testing by bringing services closer to the patient and enable timely availability of test results [4,5]. Diagnostics 2017, 7, 8; doi:10.3390/diagnostics7010008 www.mdpi.com/journal/diagnostics Diagnostics 2017, 7, 8 2 of 8 Table 1. Partners in the Global Medical Diagnostic Community. # Agency # Agency 1 Ministries of Finance & Health from Global Alliance for Vaccines Initiative (GAVI)-eligible countries 25 International Diabetes Federation (IDF) 2 Accordia Global Health Foundation 26 International Diagnostics Centre (IDC)/London School of Hygiene and Tropical Medicine (LSHTM) 3 African Society for Laboratory Medicine (ASLM) 27 International Training and Education Center for Health (I-TECH)/University of Washington 4 Asia Pacific Laboratory Accreditation Cooperation 28 In Vitro Diagnostic (IVD) manufacturers & distributors 5 American Association for the Advancement of Science (AAAS) 29 Joint United Nations Programme on HIV/AIDS (UNAIDS) 6 American Society for Clinical Pathology (ASCP) 30 Kaiser Family Foundation (KFF) USA Global Health Policy 7 American Society for Microbiology (ASM) 31 Malaria no More 8 American Society of Tropical Medicine and Hygiene (ASTMH) 32 Medicins Sans Frontieres (MSF) 9 American Thoracic Society (ATS) 33 Partnership for Supply Chain Management (SCMS) 10 Asia Pacific Laboratory Accreditation Cooperative 34 PATH 11 Bill and Melinda Gates Foundation (BMGF) 35 Research!America Global Health R&D Advocacy 12 Center for Strategic and International Studies (CSIS) Global Health Policy Center 36 Stop TB Partnership 13 Clinton Health Access Initiative (CHAI) 37 The Earth Institute 14 Consortium of Universities for Global Health (CUGH) 38 The Global Fund to Fight AIDS, Tuberculosis, and Malaria (The Global Fund) 15 CRDF Global 39 The Global Health Network 16 Foundation for Innovative New Diagnostics (FIND) 40 UN Foundation (UNF) 17 Foundation for NIH (FNIH) 41 UNITAID 18 GBCHealth 42 United States Agency for International Development (USAID) 19 Global Alliance for Chronic Diseases (GACD) 43 United States Center for Disease Control (CDC) 20 Global Health Council 44 United States National Institutes of Health (NIH) e.g., National Institute of Biomedical Imaging and Bioengineering Point-of-Care Technology Research Network 21 Global Health Innovative Technology Fund (GHIT) 45 United States President's Emergency Plan for AIDS Relief (PEPFAR) 22 Global Health Security Agenda (GHSA) 46 Wellcome Trust 23 Global Health Technologies Coalition (GHTC) 47 World Bank 24 Infectious Diseases Society of America (IDSA) 48 World Health Organization (WHO) Diagnostics 2017, 7, 8 3 of 8 Historically, there has been poor coordination of efforts between diagnostic test manufacturers and implementation of diagnostic PoC testing in target populations. From the manufacturer’s perspective, there are challenges related to estimating the demand for PoC technologies as well as defining the regulatory and distribution pathways for new diagnostic technologies [6–9]. From the demand side, many of the barriers relate to the availability of resources to introduce and implement these diagnostics [10,11]. Moreover, it is often unclear which stakeholders lead training and implementation activities. This lack of coordination slows the introduction and uptake of diagnostic technologies and limits the degree to which improved patient outcomes are realized. These challenges are not unique to the global medical diagnostics community. The global vaccine community ex (...truncated)