FDA Expands HPV Primary Screening Options - Scorecard - MDSpire
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FDA Expands HPV Primary Screening Options

Regulatory action broadens available approaches for cervical cancer screening in US clinical practice.

  • By

  • Kathryn Wighton

  • February 4, 2026

  • 2 min

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Clinical Scorecard: FDA Expands HPV Primary Screening Options

At a Glance

CategoryDetail
ConditionCervical Cancer Screening
Key MechanismsDetection of human papillomavirus (HPV) using messenger RNA to identify infections likely to lead to cervical cancer.
Target PopulationWomen aged 30 to 65 years.
Care SettingDiverse US health systems.

Key Highlights

  • Aptima HPV assay approved for primary HPV screening.
  • Targets messenger RNA, unlike traditional DNA-based tests.
  • Sensitivity comparable to existing DNA-based HPV tests.
  • Co-testing detects up to 95% of cervical cancers.
  • Over 90% of providers confident in co-testing for target age group.

Guideline-Based Recommendations

Diagnosis

  • Utilize Pap testing, Pap plus HPV co-testing, or primary HPV testing.

Management

  • Follow up on abnormal results with appropriate clinical actions.

Monitoring & Follow-up

  • Regular screening recommended to prevent cervical cancer.

Risks

  • Invasive cervical cancer cases and associated mortality.

Patient & Prescribing Data

Women across diverse demographics in the US.

Regular screening and follow-up can prevent many cervical cancer deaths.

Clinical Best Practices

  • Offer flexible screening options based on patient age and risk factors.
  • Encourage co-testing for comprehensive screening.

Related Resources & Content

Original Source(s)

FDA Expands HPV Primary Screening Options

  • by Kathryn Wighton

  • February 4, 2026

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