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HR 8939

Closing the HPV Testing Gap Act

119th Congress Introduced by Joyce Beatty and 19 co-sponsors

NIH must study and report on developing a standardized, noninvasive HPV test for men, outlining methods, feasibility, and steps toward regulatory approval and equity.

Introduced in House
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Bill Summary · HR 8939

Summary of HR 8939 — Closing the HPV Testing Gap Act

Main purpose

  • Directs the Director of the National Institutes of Health (NIH) to conduct a comprehensive study and submit a Congressional report on developing a standardized, noninvasive HPV test for men.
  • Aims to address a public health gap by evaluating how to detect HPV in men, promote gender equity in cancer prevention, and inform national cancer prevention and health equity efforts.

Key provisions and changes

  • Findings establishing context

    • HPV is the most common sexually transmitted infection in the U.S.
    • There is currently no FDA-approved, standardized HPV diagnostic test for men.
    • Expanding HPV detection to men could improve cancer prevention, surveillance, and outcomes and promote equity in prevention efforts.

  • NIH study and reporting requirement (Sec. 3)

    • The NIH Director must conduct a comprehensive study within 24 months of enactment to explore the development of a standardized, noninvasive HPV test for men.
    • The study should:
    • Assess current knowledge, gaps, and state of development for noninvasive tests in men.
    • Explore potential testing approaches and methodologies, including multi-site testing (oral, pharyngeal, anal, penile) and urine-based testing.
    • Identify considerations for future implementation, including pilot studies, population-level testing concepts, and how such testing could inform public health strategies.
    • Evaluate feasibility of pilot and implementation studies across diverse populations and multiple HPV-affected sites.
    • Develop recommendations for interagency coordination to facilitate regulatory approval (FDA) and equitable access through the FDA and Health Resources and Services Administration (HRSA).
    • Propose other pilot/feasibility studies deemed appropriate to complete the study.

  • Interagency Working Group (Sec. 3(d))

    • NIH must establish an interagency working group including representatives from:
    • FDA, CDC, HRSA, and the National Academy of Medicine.
    • Purpose: ensure coordinated implementation of the study across scientific, regulatory, and community pathways.

  • Congressional reporting (Sec. 3(e))

    • Not later than 30 months after enactment, NIH must report to Congress with:
    • Findings and conclusions from the study.
    • Recommendations for developing and implementing a standardized, noninvasive HPV test for men.
    • Interagency strategies for integrating HPV testing into national cancer prevention and health equity initiatives.

  • Definitions and funding (Sec. 3(f)-(g))

    • Clarifies definitions (Director of NIH, HPV, study).
    • Authorizes funding for fiscal years 2026–2030 to carry out the section.

Who/what would be affected

  • Directly affected entities:

    • NIH (lead agency conducting the study)
    • FDA (regulatory pathway for potential test approval)
    • CDC (public health surveillance and guidance)
    • HRSA (implementation, access, and equity considerations)
    • National Academy of Medicine (advisory and coordination role)

  • Impact on populations:

    • Men, including those in high-risk or underserved communities, could gain access to future noninvasive HPV testing.
    • Potential downstream effects on gender equity in cancer prevention and broader public health outcomes, by addressing a currently unmet diagnostic gap in men.

Procedural and timeline aspects

  • Enactment triggers starts the 24-month study period for NIH to complete the study.
  • NIH report to Congress is due within 30 months of enactment.
  • Activities include interagency coordination, stakeholder consultation, pilot feasibility planning, and potential implementation pilot considerations.
  • Funding available through NIH for fiscal years 2026–2030 to support the study and related activities.

Overall assessment

  • HR 8939 seeks to fill a recognized gap in HPV detection by systematically studying the development of a standardized, noninvasive test for men.
  • The bill emphasizes coordination across federal agencies, consideration of diverse testing modalities and sites, and the pursuit of equitable access and integration into national cancer prevention efforts.
  • It does not create a new diagnostic test or mandate enrollment; rather, it funds and directs a roadmap study with concrete milestones and a final report to Congress.

Compiled from official sources — confirm details with the bill’s official record.

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