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Principal Investigator: Rafael Guerrero-Preston
Organization: LIFEGENE-BIOMARKS, INC.
Fiscal Year: 2024
Award: $275,767
Funding agency: National Institute on Minority Health and Health Disparities
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 selfcollected 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.
Terms: <Abate><Acetic Acids><Algorithms><Blinded><Breast Cancer><Cancers><Caucasian Females><Caucasian Women><Cervical><Cervical Cancer><Cervical Cancer Screening><Cervical Intraepithelial Neoplasia><Cervical Intraepithelial Neoplasms><Cervix Cancer><Cervix Intraepithelial Neoplasia><Cervix Uteri Intraepithelial Neoplasia><Clinical><Colorectal Cancer><Communities><Complex><Country><Cytology><DNA Markers><DNA Methylation><DNA Sequence><DNA biomarkers><Disease><Disorder><Disparities><Disparity><Economic Income><Economical Income><Enrollment><Epigenetic><Epigenetic Change><Epigenetic Mechanism><Epigenetic Process><Ethnic Origin><Ethnicity><Evaluation><Fear><Federally Qualified Health Center><Fright><Future><Goals><Guidelines><HPV><HPV infection><HPV positive><HPV(+)><HPV+><HPV-High Risk><Health><Health Insurance><Health Promotion><High Risk Oncogenic HPV><High Risk Woman><High risk HPV><High risk Human Papillomavirus><High risk Human papilloma virus><Human Papilloma Virus><Human Papillomavirus><Human papilloma virus infection><Human papillomavirus infection><Incidence><Income><Infectious Human Wart Virus><Insurance Coverage><Insurance Status><Knowledge><Laboratories><Laboratory Research><Language><Latina><Latina Population><Latinas><Left><Lesion><Low Income Population><Low income><Low income group><Malignant Breast Neoplasm><Malignant Cervical Neoplasm><Malignant Cervical Tumor><Malignant Neoplasm of the Cervix><Malignant Neoplasms><Malignant Tumor><Malignant Tumor of the Cervix><Malignant Tumor of the Cervix Uteri><Malignant Uterine Cervix Neoplasm><Malignant Uterine Cervix Tumor><Malignant neoplasm of cervix uteri><Medicaid><Medical><Methylation><Montana><Oncogenic><Pap Test><Pap screening><Pap smear><Papanicolaou Smear><Papanicolaou Test><Patients><Perception><Performance><Phase><Policies><Predictive Value><Prevalence><Preventive><Privatization><Prospective Studies><Puerto Rico><Race><Races><Retrospective Studies><Risk><SBIR><Salutogenesis><Sampling><Screening for cancer><Services><Small Business Innovation Research><Small Business Innovation Research Grant><Specificity><Squamous Cell Intraepithelial Neoplasia><Squamous intraepithelial lesion><Swab><Technology><Testing><Time><Transportation><U.S. Preventative Services Task Force><U.S. Preventative Task Force><U.S. Preventive Services Task Force><U.S. Preventive Task Force><US Preventative Services Task Force><US Preventative Task Force><US Preventive Health Services Task Force><US Preventive Services Task Force><US Preventive Task Force><USPSTF><Uninsured><United States><United States Preventative Services Task Force><United States Preventative Task Force><United States Preventive Services Task Force><United States Preventive Task Force><Universities><Uterine Cervix Cancer><Uterine Cervix Intraepithelial Neoplasia><Vagina><Validation><Viral><Visit><Visual><White Females><White Women><Woman><World Health Organization><advanced disease><advanced illness><aged><at-risk females><at-risk women><biomarker development><cancer disparity><cancer health disparity><cancer-related health disparity><cervical cancer early detection><cervical screening><clinical risk><cohort><commercialization><cost><disparity in cancer><early cancer detection><enroll><epigenetically><ethnic diversity><ethnically diverse><feasibility testing><females at high risk><health insurance plan><high risk><high risk females><human papillomavirus +><human papillomavirus positive><incomes><intraepithelial><low income country><low income individual><low income people><malignancy><malignant breast tumor><medical college><medical schools><methylation testing><mortality><multiplex assay><neoplasm/cancer><novel><personalized screening><phase 1 evaluation><phase 1 testing><phase I evaluation><phase I testing><precancer><precancer cervical detection><precancerous><precision medicine><precision screening><precision-based medicine><premalignant><presence of HPV><presence of human papillomavirus><prevent><preventing><programs><promoting health><racial><racial background><racial origin><recommended screening><school of medicine><screening><screening cancer patients><screening guidelines><screening recommendations><screenings><social health determinants><tool><treatment guidelines><trial comparing><tumor><validations><wart virus><women at high risk>