H.R. 5435: Stop CMV Act of 2025

This bill, titled the Stop CMV Act of 2025, proposes amendments to the Public Health Service Act focusing on the screening of congenital Cytomegalovirus (CMV) in newborns. Here’s a breakdown of its key components:

Screening for Congenital Cytomegalovirus

The bill mandates that hospitals or health care entities caring for infants up to 21 days old conduct tests for congenital CMV. This is designed to identify CMV in newborns, which can lead to serious health issues if not detected early.

State Responsibilities

• The chief executive officer for health in each state is responsible for setting standards and procedures for administering these tests.
• This includes how the results of tests are recorded and tracked, as well as conducting follow-up reviews and educational activities.
• States are also tasked with disseminating information about the testing to parents or guardians.
• If a state does not provide its own approved standards within two years, an Advisory Committee will set these standards for the state.

Grants for Implementation

The bill provides for the awarding of grants to states that develop testing standards. These funds, coming from the Health Resources and Services Administration, are intended for use by the hospitals and health care entities administering the tests.

Collaboration with Federal Agencies

• The Centers for Disease Control and Prevention (CDC) will also provide grants to support state agencies in improving data collection systems related to CMV and educating both healthcare providers and the public about the disease.
• The National Institutes of Health (NIH) will conduct research on CMV, focusing on screening techniques, diagnostics, prevention, treatment, and potential vaccines.

Advisory Committee Role

The bill adds responsibilities to the Advisory Committee on Heritable Disorders in Newborns and Children, requiring them to carry out related activities aligned with the new screening mandate.

Funding Authorization

The bill authorizes necessary appropriations to support the activities of the grants and the collaborations between state and federal agencies for the fiscal years 2025 and 2026.

Relevant Companies

• INCY - Incyte Corporation may be involved in developing treatments for CMV or diagnostics, which could be impacted by increased research funding and focus.
• ABBV - AbbVie Inc. might engage in developing therapies or vaccines once more funding is allocated for CMV research and treatment initiatives.