CervicalMethDx: A precision tool to enable at-home sampling and expand access to cervical cancer prevention while reducing unnecessary biopsies in the United States and Puerto Rico.

CervicalMethDx is a molecular precision tool designed to expand access to cervical cancer prevention through self-collection while reducing unnecessary biopsies. Two cohorts were analyzed: women from Salud Integral en la Montaña (SIM, n = 82) and the University of Puerto Rico School of Medicine (UPR, n = 105) cervical cancer clinics who participated in an IRB-approved study comparing CervicalMethDx and Human Papilloma Virus (AmpFire, Atila BioSystems) test results in physician-collected (PreservCyt, Hologic) and self-collected vaginal swabs (MSwabs, Copan). Participants completed structured questionnaires assessing demographics, reproductive and screening histories, and experiences using the LifeGene BioMarks self-collection kit. Acceptability and preference of sampling methods were evaluated using Likert scales. Cramér's V was used to measure associations between sample collection preference and participant characteristics. Additional acceptability data of self-sampling were collected through 300 structured interviews with women from Puerto Rico, the United States, and Latin America attending Bad Bunny's Residencia concerts in Puerto Rico and through an online market study of 2,800 statistically representative women from seven municipalities in rural Puerto Rico served by SIM. Health-economic modeling used biopsy data from UPR clinics (2022-2024, n = 422) and BRFSS data (2016-2020) to estimate cost savings from reduced unnecessary biopsies. Self-collection was highly acceptable: 88-94% “would do at home,” 87-95% “satisfied,” and >95% “recommend to others.” SIM participants more often preferred self-collection (52%) than UPR participants (42%), where physician collection remained preferred (48%). Employment and education showed modest influence on preference (Cramér's V = 0.27 and 0.16, respectively). Community market study revealed 86% willingness to self-test if validated, affordable, and endorsed by physicians. In the online sample, 72% expressed intent to use at-home kits. Motivators included convenience (50%), privacy (49%), and time savings (48%), while concerns centered on accuracy (50%) and correct use (45%). Pharmacies were the preferred distribution channel (73%). Health-economic modeling showed that applying CervicalMethDx rule-out thresholds could reduce unnecessary biopsies from 81% to 10-25%, translating into potential savings of $16.7-23.2M annually in Puerto Rico and $2.0-2.7B in the U.S. CervicalMethDx demonstrates high acceptability across diverse settings and potential to reduce unnecessary procedures and healthcare costs, supporting its integration into cervical cancer screening algorithms.