Adam Vasserstrom

PhD

Nucleix

VP bioinformatics

NLST (Learn more about this study)

NLST-965

Oct 11, 2022

Lung cancer risk assessment

Developing simpler and more accessible means to screen for lung cancer than low-dose CT is critical for widespread adoption and realization of the survival benefit of screening at-risk populations. Liquid biopsy with high accuracy would be ideal to screen for lung cancer in a cost-effective manner in a community setting. Lung EpiCheck is a simple blood test that uses circulating-tumor DNA to identify cancer DNA in a panel of biomarkers of quantitative methylation patterns. The ultra-sensitive biochemical assay allows identification of a single cancer molecule on a background of 200,000 normal molecules. The lung EpiCheck test yields a qualitative result (i.e. negative/positive) which is based on a predefined cut-off score which is calculated by an algorithm developed in our bioinformatics lab. The 1st generation of Lung EpiCheck performance were validated in 179 cases and 137 controls and achieved sensitivity/specificity of 87%/64% with a low cut-off (favoring sensitivity) and sensitivity/specificity of 91%/74% with a high cut-off (favoring specificity) [Gaga et al. Eur Respir J 2021;57(1):2002682]. In that analysis, adding risk factors has increased the test accuracy from 0.882 to 0.942. We are now in the process of developing the 3rd generation of Lung EpiCheck, and our goal is to assess the performance of Lung EpiCheck in lung cancer screening in conjunction with risk factors. We would use the NLST study population data to determine/assess the contribution of the various risk factors to the overall risk of the subjects and their correlation with the methylation signal from cfDNA