# Precision screening in self-collected samples to reduce cervical cancer disparities among Latinas

> **NIH NIH R42** · LIFEGENE-BIOMARKS, INC. · 2024 · $275,767

## 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. Cervical cancer incidence and mortality has been higher for decades among Latinas in the 
United States (US) [8]. A recent study found that cervical cancer incidence is 32 percent higher among 
Latinas in the 50 states and 78 percent higher in the US territory of Puerto Rico, compared to non-Latina
white women. The screening rates among Latinas is also. The World Health Organization (WHO) 2021
guidelines for treatment of cervical intraepithelial neoplasia 2-3 and screen-and-treat strategies to
prevent cervical cancer, includes DNA methylation in the screening algorithm. A variety of alternative 
algorithms are being used for cervical cancer screening in low-income populations, which include
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. Testing DNA biomarkers in self 
collected vaginal swabs can increase cancer screening rates and lead to a reduction in cervical cancer 
disparities among Latinas in the US. In this Fast Track SBIR project, we propose to demonstrate the
feasibility for the commercialization of a precision methylation test in self-collected swabs among Latinas,
using the Precision Cervical Health Promotion program using the CervicalMethDx test, to stratify selfcollected swab of HPV+ patients for high risk of cervical cancer. The CervicalMethDx 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 self-collected samples. We are
partnering with Salud Integral en la Montaña, PathAdvantage Clinical laboratory and, David Sidransky’s 
research laboratory to implement the Precision Cervical Health Promotion and optimize CervicalMethDx
Test in self-collected samples, to introduce precision epigenetic services to Latinas in the US and the 
territory of Puerto Rico.

## Key facts

- **NIH application ID:** 10601924
- **Project number:** 1R42MD018231-01
- **Recipient organization:** LIFEGENE-BIOMARKS, INC.
- **Principal Investigator:** Rafael Guerrero-Preston
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $275,767
- **Award type:** 1
- **Project period:** 2024-06-01 → 2024-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10601924

## Citation

> US National Institutes of Health, RePORTER application 10601924, Precision screening in self-collected samples to reduce cervical cancer disparities among Latinas (1R42MD018231-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10601924. Licensed CC0.

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