Closing the HPV Testing Gap Act

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.