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
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. References
