National Institute on Minority Health and Disparities Awards $2.1M to LifeGene-Biomarks to develop CervicalMethDx test in self-collected swabs

The National Institute on Minority Health and Disparities awards a $2.1M Fast-Track Phase 1/Phase 2 Small Business Technology Transfer Research grant to LifeGene-Biomarks, Inc. for the project titled: Precision screening in self-collected samples to reduce cervical cancer disparities among Latinas. The objective of this project is to demonstrate the feasibility for the commercialization of a precision DNA methylation test, the CervicalMethDx Test, to stratify patients at high risk of cervical cancer. 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.

LifeGene-Biomarks is partnering with Salud Integral en la Montaña, the largest Federally Qualified Health Center in Puerto Rico. PathAdvantage Clinical laboratory in Texas and, David Sidransky’s research laboratory in Johns Hopkins School of Medicine to implement the Precision Cervical Health Promotion Program and optimize CervicalMethDx Test in self-collected samples, introducing precision epigenetic services to Latinas in the US and the territory of Puerto Rico.