FDA Clears At-Home HPV Screening Tool
Self-collection approach aims to expand screening access
By
Kathryn Wighton
April 8, 2026
Clinical Scorecard: FDA Clears At-Home HPV Screening Tool
At a Glance
Category Detail
Condition Cervical Cancer Screening Key Mechanisms Detection of high-risk HPV genotypes associated with cervical cancer. Target Population Individuals at risk for cervical cancer, particularly those unscreened or under-screened. Care Setting At-home self-collection for laboratory analysis.
Key Highlights
FDA approval of Onclarity HPV self-collection kit for at-home use. Increases access to cervical cancer screening options. Targets the 60% of cases occurring in unscreened or under-screened patients. Utilizes the BD Onclarity HPV Assay for high-risk genotype detection. Results transmitted to healthcare providers for follow-up care. Guideline-Based Recommendations
Diagnosis
Utilize the BD Onclarity HPV Assay for high-risk HPV detection. Management
Facilitate timely follow-up and management based on screening results. Monitoring & Follow-up
Monitor screening uptake and patient adherence to follow-up care. Risks
Potential barriers to access and adherence in cervical cancer screening. Patient & Prescribing Data
Patients at risk for cervical cancer, particularly those who are unscreened.
Expected to be covered by private insurance, Medicaid, and Medicare.
Clinical Best Practices
Encourage at-home sample collection to improve screening participation. Establish partnerships to expand access to self-collection kits. References
