FDA Expands HPV Primary Screening Options
Regulatory action broadens available approaches for cervical cancer screening in US clinical practice.
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By
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Kathryn Wighton
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February 4, 2026
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Clinical Scorecard: FDA Expands HPV Primary Screening Options
At a Glance
| Category | Detail |
|---|
| Condition | Cervical Cancer Screening |
| Key Mechanisms | Detection of human papillomavirus (HPV) using messenger RNA to identify infections likely to lead to cervical cancer. |
| Target Population | Women aged 30 to 65 years. |
| Care Setting | Diverse 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.
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