H.R. 1108: Diagnostics Testing Preparedness Plan Act of 2025

This bill, known as the Diagnostics Testing Preparedness Plan Act of 2025, proposes to enhance the United States' capability to respond to public health emergencies through improved diagnostic testing. Specifically, the bill mandates the Secretary of Health and Human Services to develop a comprehensive plan that focuses on several key areas regarding diagnostics during times of health crises, such as those posed by infectious diseases or bioterrorism.

Key Provisions of the Bill

The bill outlines several important components:

• Diagnostic Testing Preparedness Plan: The Secretary is required to create and regularly update a detailed plan. This plan should cover the rapid development, validation, authorization, manufacture, procurement, and distribution of diagnostic tests in response to public health emergencies.
• Coordination and Collaboration: The plan aims to facilitate better coordination and collaboration among various stakeholders involved in diagnostic testing, including public entities, private manufacturers, clinical laboratories, and local and state governments.
• Domestic Capacity Consideration: The plan will consider the domestic capacity for developing and distributing diagnostic tests, including partnerships with private sector entities to enhance capabilities.
• Utilization of New Technologies: It addresses the incorporation of novel technologies that could improve testing capabilities. This includes high-throughput laboratory diagnostics, point-of-care testing, and rapid at-home tests.
• Medical Supply Needs: The bill emphasizes the importance of assessing the needs for medical supplies related to testing, as well as ensuring there are strategies in place to distribute tests efficiently across various regions.

Implementation Timeline

The bill sets clear deadlines for the rollout of the plan:

• The Secretary must publicly release the initial plan within one year of the bill's enactment.
• Subsequent updates to the plan must occur at least once every three years.

General Goals

The overarching goal of this bill is to improve the nation's responsiveness to potential public health emergencies by ensuring that diagnostic testing can be developed and deployed quickly and effectively. By creating a robust framework and encouraging collaboration among various entities, the bill aims to mitigate the impact of future health crises.

Relevant Companies

• BDX (Becton, Dickinson and Company) - A major medical technology company involved in the design and manufacture of diagnostics and medical devices. The bill could increase demand for their diagnostic products during health emergencies.
• ABT (Abbott Laboratories) - Known for its diagnostics solutions, Abbott may experience changes in testing demand and product development based on the plans laid out in the bill.
• TMO (Thermo Fisher Scientific Inc.) - Involved in the production of diagnostic equipment and tests. The increased emphasis on rapid testing could affect their operations and product offerings.
• PFE (Pfizer Inc.) - As a pharmaceutical company that has also been engaged in diagnostic testing during health crises, they might adapt their strategies in line with the new regulatory landscape fostered by the bill.