Proposal for a national diagnostics action plan for the United States.

Providing a definitive diagnostic test in a disease emergency is critical to limit pathogen spread, develop and deploy medical countermeasures, and mitigate the social and economic harms of a serious epidemic. While major accomplishments have accelerated test development, expanded laboratory testing capacity, and established widespread point-of-care testing, the United States does not have a plan to rapidly respond, to develop, manufacture, deploy, and sustain diagnostic testing at a national scale. To address this gap, we are proposing a National Diagnostics Action Plan that describes the steps that are urgently needed to prepare for future infectious disease emergencies, as well as the actions we must take at the first signs of such' events. These recommendations require substantial collaboration between the US government (USG) and the private sector to solve a series of challenges now, as well as to prepare for the massive and rapid scale-up of laboratory and point-of-care test development and testing capacity in future emergencies. The recommendations include establishing pre-event contracts; ensuring rapid access to clinical samples; creating a permanent public-private testing coordinating body to allow for rapid information sharing and improved cooperation among the USG, test developers, and clinical laboratories; and accelerating testing rollout at the beginning of an event-and thus, the effective public health management of a disease crisis.

Strengthen oversight of risky research on pathogens.

Policy reset and convergence on governance are needed.

Strengthening Security for Gene Synthesis: Recommendations for Governance.

Since the inception of gene synthesis technologies, there have been concerns about possible misuse. Using gene synthesis, pathogens-particularly small viruses-may be assembled "from scratch" in the laboratory, evading the regulatory regimes many nations have in place to control unauthorized access to dangerous pathogens. Progress has been made to reduce these risks. In 2010, the US Department of Health and Human Services (HHS) published guidance for commercial gene synthesis providers that included sequence screening of the orders and customer screening. The industry-led International Gene Synthesis Consortium (IGSC) was formed in 2009 to share sequence and customer screening methods, and it now includes the major international gene synthesis providers among its members. Since the 2010 HHS Guidance was released, however, there have been changes in gene synthesis technologies and market conditions that have reduced the efficacy of these biosecurity protections, leading to questions about whether the 2010 HHS Guidance should be updated, what changes could make it more effective, and what other international governance efforts could be undertaken to reduce the risks of misuse of gene synthesis products. This article describes these conditions and recommends actions that governments should take to reduce these risks and engage other nations involved in gene synthesis research.

Clade X: A Pandemic Exercise.

Clade X was a day-long pandemic tabletop exercise conducted by the Johns Hopkins Center for Health Security on May 15, 2018, in Washington, DC. In this report, we briefly describe the exercise development process and focus principally on the findings and recommendations that arose from this project.

Southeast Asia Strategic Multilateral Dialogue on Biosecurity.

A strategic multilateral dialogue related to biosecurity risks in Southeast Asia, established in 2014, now includes participants from Singapore, Malaysia, Indonesia, Thailand, Philippines, and the United States. This dialogue is conducted at the nonministerial level, enabling participants to engage without the constraints of operating in their official capacities. Participants reflect on mechanisms to detect, mitigate, and respond to biosecurity risks and highlight biosecurity issues for national leadership. Participants have also identified factors to improve regional and global biosecurity, including improved engagement and collaboration across relevant ministries and agencies, sustainable funding for biosecurity programs, enhanced information sharing for communicable diseases, and increased engagement in international biosecurity forums.

Design of the national health security preparedness index.

The importance of health security in the United States has been highlighted by recent emergencies such as the H1N1 influenza pandemic, Superstorm Sandy, and the Boston Marathon bombing. The nation's health security remains a high priority today, with federal, state, territorial, tribal, and local governments, as well as nongovernment organizations and the private sector, engaging in activities that prevent, protect, mitigate, respond to, and recover from health threats. The Association of State and Territorial Health Officials (ASTHO), through a cooperative agreement with the Centers for Disease Control and Prevention (CDC) Office of Public Health Preparedness and Response (OPHPR), led an effort to create an annual measure of health security preparedness at the national level. The collaborative released the National Health Security Preparedness Index (NHSPI(™)) in December 2013 and provided composite results for the 50 states and for the nation as a whole. The Index results represent current levels of health security preparedness in a consistent format and provide actionable information to drive decision making for continuous improvement of the nation's health security. The overall 2013 National Index result was 7.2 on the reported base-10 scale, with areas of greater strength in the domains of health surveillance, incident and information management, and countermeasure management. The strength of the Index relies on the interdependencies of the many elements in health security preparedness, making the sum greater than its parts. Moving forward, additional health security-related disciplines and measures will be included alongside continued validation efforts.