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

Award Number: R42MD018231
ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2024
PERIOD OF PERFORMANCE END DATE: 11/30/2026

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Precision screening in self-collected samples to reduce cervical cancer disparities among Latinas - 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 differences exist worldwide. The dramatic difference 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 differences 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 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 incidence differences among Latinas in the US. In this Fast Track STTR 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $1,456,725 )
2025	2025	LIFEGENE- BIOMARKS INC	1612 AVE PONCE DE LEON	SAN JUAN	PR	00909	SAN JUAN	USA	Minority Health and Health Disparities Research	000	2	11/28/2024	EXTENSION WITH OR WITHOUT FUNDS	$885,429
2025	2025	LIFEGENE- BIOMARKS INC	1612 AVE PONCE DE LEON	SAN JUAN	PR	00909	SAN JUAN	USA	Minority Health and Health Disparities Research	002	2	4/28/2025	EXTENSION WITH OR WITHOUT FUNDS	$98,378
2025	2025	LIFEGENE- BIOMARKS INC	1612 AVE PONCE DE LEON	SAN JUAN	PR	00909	SAN JUAN	USA	Minority Health and Health Disparities Research	003	2	9/11/2025	EXTENSION WITH OR WITHOUT FUNDS	$472,918
2025	2024	LIFEGENE- BIOMARKS INC	1612 AVE PONCE DE LEON	SAN JUAN	PR	00909	SAN JUAN	USA	Minority Health and Health Disparities Research	001	1	4/22/2025	NEW	$0
														Subtotal = $1,456,725

Issue Date FY: 2024 ( Subtotal = $275,767 )
2024	2024	LIFEGENE- BIOMARKS INC	1612 AVE PONCE DE LEON	SAN JUAN	PR	00909	SAN JUAN	USA	Minority Health and Health Disparities Research	000	1	4/22/2024	NEW	$275,767
														Subtotal = $275,767

Grand Total All Awards = $1,732,492

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

Award Number: R42MD018231

ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/01/2024

PERIOD OF PERFORMANCE END DATE: 11/30/2026

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