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 estab-lished 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 infec-tious disease emergencies, as well as the actions we must take at the first signs of such' events. These recom-mendations 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 coor-dinating body to allow for rapid information sharing and improved cooperation among the USG, test develop-ers, and clinical laboratories; and accelerating testing rollout at the beginning of an event-and thus, the effective public health management of a disease crisis.