§2.Improving development and distribution of diagnostic tests
This section revises section 319B of the Public Health Service Act (42 U.S.C. 247d–2) to require the Secretary of Health and Human Services to develop, publicly release, and update a diagnostic testing preparedness plan for chemical, biological, radiological, or nuclear threats, including emerging infectious diseases that have a public health emergency declared under section 319 of the Public Health Service Act or that have significant potential to cause such an emergency. The plan must address the rapid development, validation, authorization, manufacture, procurement, and distribution of diagnostic tests, as well as the rapid scaling of testing capacity.
As background, section 319B currently supports federal preparedness for diagnostic testing during public health emergencies. The revised provision expands and specifies that planning must facilitate coordination and collaboration among public and private entities and must describe the processes for testing development and distribution.
The section requires the plan to consider: (1) domestic capacity, including capacity developed through public-private partnerships; (2) novel technologies and platforms, including high-throughput laboratory diagnostics, point-of-care diagnostics, and rapid at-home diagnostics; (3) medical supply needs and vulnerabilities related to testing equipment, supplies, and component parts, consistent with section 2811(b)(4)(J); (4) strategies for rapid local, regional, or nationwide distribution of tests and appropriate laboratory scaling; and (5) assessment of those strategies through drills and operational exercises under section 2811(b)(4)(G), as appropriate.
The section also directs the Secretary to coordinate with industry, including device manufacturers, clinical and reference laboratories, and medical product distributors, as well as States, local governmental entities, Indian Tribes and Tribal organizations, and other relevant public and private entities. It authorizes the Secretary to contract with public and private entities to increase domestic capacity for diagnostic test development and distribution to State, local, and Tribal health departments and other appropriate entities for immediate public health response activities.
Finally, the section requires the Secretary to publicly release the plan not later than 1 year after enactment of the Diagnostics Testing Preparedness Plan Act of 2025 and to update the plan at least once every 3 years after the initial public release.