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Precision methylation biomarkers linked to cancer disparities

Award Number: R44MD014911
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: 09/24/2019
PERIOD OF PERFORMANCE END DATE: 05/31/2022

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Precision methylation biomarkers linked to cancer disparities - Project Summary No woman should die of cervical cancer, yet cervical cancer is the third leading malignancy among women in the world, after breast cancer and colorectal cancer. Cervical cancer is also one of the tumors in which the most glaring disparities exist worldwide. Cervical cancer incidence and mortality has been higher for decades among Latinas in the United States (US). However, a recently published study revealed that cervical cancer death rates among White and Black women in the US are much higher than previously thought, after adjusting for the number of hysterectomies performed. Black women are dying from cervical cancer at a rate 77% higher than previously thought, and white women are dying at a rate 47% higher. The disparity in cervical cancer mortality rates by race doubled, from 2.7 to 5.4 per 100,000 women, after removing women with hysterectomies from mortality calculations. Presumably, the same is the case for Latina women, but there is currently no data available to verify if this is the case. The use of cytology screening (Pap smear) and oncogenic Human papilloma Virus (HPV+) genotyping are effective in identifying women who may be at risk for cervical cancer, but cannot be used to predict who is more likely to develop cervical carcinoma. Current standard of practice in the US for women with persistent HPV+ infection and abnormal Pap is referral to colposcopy and subsequent biopsy. However, most of these biopsies (55%-70%) are performed in women without clinical disease The goal of this project is to demonstrate the feasibility for the commercialization of the CervicalMethDx Test, a precision methylation for the cervical cancer screening space. We will focus on patients with persistent oncogenic Human Papilloma Virus (HPV+) infection, who are referred into colposcopy and subsequent biopsy, even when most will have a normal biopsy. We are partnering with David Sidransky's research laboratory to optimize the CervicalMethDx Test and with the Education and Outreach Department of the Johns Hopkins Sidney Kimmel Cancer Center to introduce precision epigenetic services to residents of low-income neighborhoods in Baltimore. Efficient triage of HPV+ women into colposcopy will decrease unnecessary biopsies, improve health care quality, decrease health care costs, and reduce existing cervical cancer mortality disparities in the US.


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: 2023 ( Subtotal = $0 )
2023	2021	LIFEGENE- BIOMARKS INC	1612 AVE PONCE DE LEON	SAN JUAN	PR	00909	SAN JUAN	USA	Minority Health and Health Disparities Research	000	3	1/23/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $733,762 )
2021	2021	LIFEGENE- BIOMARKS, INC	1612 AVENIDA PONCE DE LEON	SAN JUAN	PR	00909	SAN JUAN	USA	Minority Health and Health Disparities Research	001	3	4/30/2021	NON-COMPETING CONTINUATION	$733,762
2021	2019	LIFEGENE- BIOMARKS, INC	1612 AVENIDA PONCE DE LEON	SAN JUAN	PR	00909	SAN JUAN	USA	Minority Health and Health Disparities Research	000	1	11/17/2020	NEW	$0
														Subtotal = $733,762

Issue Date FY: 2020 ( Subtotal = $802,513 )
2020	2020	LIFEGENE- BIOMARKS, INC	1612 AVENIDA PONCE DE LEON	SAN JUAN	PR	00909	SAN JUAN	USA	Minority Health and Health Disparities Research	000	2	6/23/2020	EXTENSION WITH OR WITHOUT FUNDS	$802,513
2020	2020	LIFEGENE- BIOMARKS, INC	1612 AVENIDA PONCE DE LEON	SAN JUAN	PR	00909	SAN JUAN	USA	Minority Health and Health Disparities Research	002	2	6/25/2020	EXTENSION WITH OR WITHOUT FUNDS	$0
2020	2019	LIFEGENE- BIOMARKS, INC	1612 AVENIDA PONCE DE LEON	SAN JUAN	PR	00909	SAN JUAN	USA	Minority Health and Health Disparities Research	001	1	6/25/2020	NEW	$0
														Subtotal = $802,513

Issue Date FY: 2019 ( Subtotal = $206,042 )
2019	2019	LIFEGENE- BIOMARKS, INC	1612 AVENIDA PONCE DE LEON	SAN JUAN	PR	00909	SAN JUAN	USA	Minority Health and Health Disparities Research	000	1	9/24/2019	NEW	$206,042
														Subtotal = $206,042

Grand Total All Awards = $1,742,317

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Precision methylation biomarkers linked to cancer disparities

Award Number: R44MD014911

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: 09/24/2019

PERIOD OF PERFORMANCE END DATE: 05/31/2022

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