What is the clinical evidence from this study?

Study design: Observational. Population: Cervical cancer screening (n=3709). Intervention: CervicalMethDx self-collection vs. Physician-collected swabs. Primary outcome: Acceptability and preference of sampling methods, and potential reduction in unnecessary biopsies.

What question did this study set out to answer?

The aim is to assess the performance and acceptability of CervicalMethDx for cervical cancer prevention through self-collection.

April 5, 2026

Abstract 6334: 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

Key Result

Self-collection using CervicalMethDx was highly acceptable (88-94% willingness to use at home) and could reduce unnecessary biopsies from 81% to 10-25% based on health-economic modeling.

Key Points

The aim is to assess the performance and acceptability of CervicalMethDx for cervical cancer prevention through self-collection.
Analyzed two cohorts of women from cervical cancer clinics in Puerto Rico and the U.S.
Compared results of CervicalMethDx with standard physician-collected samples.
Conducted structured interviews and surveys on preferences and acceptability of self-sampling.
Performed health-economic modeling using biopsy data to estimate cost savings.
Self-collection was accepted by 88-94% of participants, with high satisfaction and recommendation rates.
Health-economic modeling predicted a reduction of unnecessary biopsies from 81% down to 10-25%.
Estimated annual savings of $16.7-23.2M in Puerto Rico and $2.0-2.7B in the U.S. associated with reduced biopsies.

Study Design

Type

Observational (n=3,709)

Multicenter

Yes

Structured PICO

Does CervicalMethDx self-collection offer an acceptable alternative to physician collection and reduce unnecessary biopsies in women undergoing cervical cancer screening?

Population

Women from Salud Integral en la Montaña (SIM, n=82) and University of Puerto Rico School of Medicine (UPR, n=105) cervical cancer clinics, along with 300 interviewees, 2,800 online survey participants, and 422 biopsy records.

Intervention

CervicalMethDx molecular precision tool via self-collected vaginal swabs

Comparator

Physician-collected swabs

Outcome

Acceptability and preference of sampling methods evaluated using Likert scalespatient reported

CervicalMethDx self-sampling is highly acceptable to women and has the potential to significantly reduce unnecessary biopsies and healthcare costs in cervical cancer screening.

Abstract

Abstract 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. Citation Format: Ashley Ramos Lopez, Yanira Gonzalez Rodriguez, Amanda Garcia Negron, Paola Quinonez Mendez, Guie Beeu Guerrero Hunt, Adhi Guerrero Thillet, Mariana Brait, Teresa Díaz-Montes, Josefina Romaguera, Lourdes Fernadez, David Sidransky, Rafael E. Guerrero-Preston. 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 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 6334.

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