LIFEGENE- BIOMARKS, INC — Department of Health and Human Services SBIR Phase I: 102

Description

Project Summary No woman should die of cervical canceryet cervical cancer is the third leading malignancy among women in the worldafter breast cancer and colorectal cancerCervical cancer is also one of the tumors in which the most glaring disparities exist worldwideCervical cancer incidence and mortality has been higher for decades among Latinas in the United StatesUSHowevera recently published study revealed that cervical cancer death rates among White and Black women in the US are much higher than previously thoughtafter adjusting for the number of hysterectomies performedBlack women are dying from cervical cancer at a ratehigher than previously thoughtand white women are dying at a ratehigherThe disparity in cervical cancer mortality rates by race doubledfromtoperwomenafter removing women with hysterectomies from mortality calculationsPresumablythe same is the case for Latina womenbut there is currently no data available to verify if this is the caseThe use of cytology screeningPap smearand oncogenic Human papilloma VirusHPVgenotyping are effective in identifying women who may be at risk for cervical cancerbut cannot be used to predict who is more likely to develop cervical carcinomaCurrent standard of practice in the US for women with persistent HPVinfection and abnormal Pap is referral to colposcopy and subsequent biopsyHowevermost of these biopsiesare performed in women without clinical disease The goal of this project is to demonstrate the feasibility for the commercialization of the CervicalMethDx Testa precision methylation for the cervical cancer screening spaceWe will focus on patients with persistent oncogenic Human Papilloma VirusHPVinfectionwho are referred into colposcopy and subsequent biopsyeven when most will have a normal biopsyWe are partnering with David Sidranskyandapos 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 BaltimoreEfficient triage of HPVwomen into colposcopy will decrease unnecessary biopsiesimprove health care qualitydecrease health care costsand reduce existing cervical cancer mortality disparities in the US Narrative The goal of this project is to demonstrate the feasibility for the commercialization of the CervicalMethDx Testa precision methylation for the cervical cancer screening spaceWe will focus on patients with persistent oncogenic Human Papilloma VirusHPVinfectionwho are referred into colposcopy and subsequent biopsyeven when most will have a normal biopsyTriage into colposcopy will decrease unnecessary biopsies and improve health care qualityparticularly among low income Latina and African American women who have a higher burden of cervical cancer in the United States!