LifeGeneBiomarks to Develop OralMethDx Test in Saliva

The National Cancer Institute awards a $2.2M Fast-Track Phase 1/Phase 2 Small Business Innovation Research grant to LifeGene-Biomarks, Inc. for the project titled: Precision DNA methylation test to reduce oral cancer disparities in patients residing in low-resource settings.

The objective of this project is to demonstrate the feasibility for the commercialization of a precision DNA methylation test, the OralMethDx Test, to stratify patients at high risk of oral cancer. Despite advances in treatments, the 5-year survival rates for oral cancer have not improved for the past 25 years. Oral cancer is a very aggressive tumor, and most patients display advanced disease at diagnosis. Most Oral cancer cases worldwide are detected at later stage of cancer because screening is not routinely conducted, leading to disparities at diagnosis based on rurality, race, ethnicity, and gender, which can be reduced by targeted screening.

Oral cancer is 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 developed countries like the US where the burden of oral cancer is highest in low-income populations. Oral cancer molecular screening should be included in dental visits for adults because early detection of oral cancer is associated with better survival.

We propose to evaluate the performance of the OralMethDx test for two separate indications: A saliva test for risk stratification in screening and early detection; and a tissue biopsy test for diagnosis and prognostication.