# Precision methylation biomarkers for cervical cancer prevention in low resource settings in Latin America

> **NIH NIH R44** · LIFEGENE-BIOMARKS, INC. · 2022 · $1,000,000

## Abstract

Project Summary
No woman should die from cervical cancer. We have the technical, medical and policy tools and approaches
to eliminate it. Yet, one woman dies of cervical cancer every two minutes. Cervical cancer is the third leading
malignancy among women in the world, after breast and colorectal cancer. Cervical cancer is also one of the
tumors in which the most glaring disparities exist worldwide. The dramatic disparity in incidence rates
between high- and low-income countries is due primarily to differential access to effective screening and pre-
cancer, or preventive, treatment; similar disparities also exist within countries. Recently published
hysterectomy-corrected cervical cancer mortality rates in the United States reveal a larger racial disparity in
black women, that previously calculated and shows that the oldest black women have the highest cervical
cancer mortality rates. Nonetheless, more than 80 percent of cases and 88 percent of deaths occur in Low
and Middle Income Countries (LMICs). The World Health Organization (WHO) has developed guidelines for
treatment of cervical intraepithelial neoplasia 2-3 and screen-and-treat strategies to prevent cervical cancer.
In countries where multiple barriers exist for cytology based cervical cancer screening, a variety of alternative
algorithms are being used, which include low-cost oncogenic HPV testing, visual inspection with acetic acid,
and self-collected vaginal swabs. HPV testing is an excellent alternative to cytology for cervical cancer
screening. However, HPV tests identifies women at risk for cervical cancer, but not those HPV-positive
women who are most likely to have, or to develop in the near future, significant disease requiring treatment.
Current practice is to triage these women by further testing with cytology and colposcopy-driven biopsies in
developed countries and excision or ablation therapy in LMICs. The use of DNA biomarkers can reduce the
number of women referred to colposcopy while maintaining adequate sensitivity and specificity. In this Fast
Track SBIR project, we propose to demonstrate the feasibility for the commercialization of a precision
methylation test, the CervicalMethDx Test, to stratify HPV+ patients for high risk of cervical cancer, as a reflex
test to existing standard of care in LMICs. Our test will enable identification of HPV+ women at clinical risk for
advancement from low-grade squamous intraepithelial lesions (LSIL) to Cervical Intraepithelial Neoplasia
grade 3 (CIN3). In LMICs, where cervical cytology based-screening will not be implemented, optional
modalities of our test will be developed in future projects to stratify HPV+ women at high risk of cervical
cancer in self-collected vaginal swabs and/or urine samples. We are partnering with David Sidransky's
research laboratory to optimize the CervicalMethDx Test and with the ESTAMPA Study (NCT01881659)
Consortium to introduce precision epigenetic services to residents of Honduras, Colombia, Argentina...

## Key facts

- **NIH application ID:** 10654910
- **Project number:** 4R44CA254690-02
- **Recipient organization:** LIFEGENE-BIOMARKS, INC.
- **Principal Investigator:** Rafael Guerrero-Preston
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,000,000
- **Award type:** 4N
- **Project period:** 2021-09-15 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10654910

## Citation

> US National Institutes of Health, RePORTER application 10654910, Precision methylation biomarkers for cervical cancer prevention in low resource settings in Latin America (4R44CA254690-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10654910. Licensed CC0.

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