Endurance of HPV Self-Collection for Disease Detection: Histopathological Follow-Up

Background: HPV self-collection (SC) expands access to cervical cancer screening (CCS) and is equivalent to clinician-collected (CC) sampling. Longer-term histopathological data after SC is essential to ensure durable sensitivity. Methods: 599 enrolled in the SELF-CERV study evaluating the Teal Wand SC device and underwent SC and CC primary HPV testing at baseline (reported previously1), with SoC colposcopy and biopsy/excisions per guidelines. Pathology results were collected after baseline to 490 days for secondary analysis to fill the evidence gap. Diagnostic performance metrics (Sen, Sp, negative predictive value-NPV) and cumulative incidence rate (CIR) were calculated for SC versus CC HPV testing among those with high grade squamous intraepithelial lesions (HSIL) or worse (CIN2+). Results: Of 599 paired SC and CC HPV results, 280 (46.7%) had pathology results within 490 days of the study visit and 57 (9.5%) were diagnosed with CIN2+. SC HPV testing showed high Sen for CIN2+, equivalent to CC testing (TABLE), ratio of Sen 1.00, similar to that observed at baseline, ratio 1.00). The NPV amongst those with pathology was 96.7% (59/61). The CIR per genotype group was not statistically significantly different for SC and CC: HPV16 had the highest ratio both at the study visit (SC: 31%, CC: 33%) and at 16 months later (SC: 47%, CC: 49%), followed by 12 Other HPV (SC: 17%, CC: 18% at study visit; SC: 24%, CC: 25% at 16 mo), and HPV18 (SC &CC: 5% at study visit, SC & CC: 21% at 16 mo). Conclusions: SC HPV testing maintained high Sen for detection of CIN2+ in the 16 mo following study enrollment and high NPV of a SC HPV negative, both equivalent to CC. Impact: To our knowledge, this is the first prospective study to evaluate pathology outcomes up to 16 mo following HPV SC, which strengthens confidence in SC as an effective CCS option that expands access, ensures appropriate clinical triage following SC, and warrants further inclusion in CCS guidelines. 1 https://pubmed.ncbi.nlm.nih.gov/40388167/ Citation Format: Sangini Sheth, Megan Fitzpatrick, Karl Hibler, Catherine Behrens. Endurance of HPV self-collection to detect disease: Histopathological follow up up to 16 months [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2026; Part 1 (Regular Abstracts); 2026 Apr 17-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86(7 Suppl):Abstract nr 5106.