Clinical Application of Rapid PCR and Computational Digital Pathology for Cancer Diagnostics: A showcase for Advanced Lung Cancer Management

Abstract

Abstract Introduction/Objective While there has been a significant increase in our understanding of the molecular changes that occur during cancer growth, the clinical efficacy of molecular testing for cancer diagnosis treatment for advanced cancers has been limited .The objective of this project is to determine the use of rapid molecular tests with same-day turn-around-time (TAT) for tumor mutations and the application of objective AI-based digital scoring methods of Immunohistochemistry test for PD-L1 for Keytruda® (Pembrolizumab). These targeted therapies for various cancers will improve patient care by reducing turnaround time and increasing diagnostic accuracy of cancer biomarker testing. Methods/Case Report A combination of rapid EGFR assays, IHC for PDL1 and digital pathology scoring was used. The data received was then used for genome-wide correlation analysis of human gene CD274 and the RNA-seq dataset from The Cancer Genome Atlas (TCGA). Results (if a Case Study enter NA) Our preliminary study results showed that there is a correlation between Micro-RNA expression of PD-L1 and immunohistochemistry PD-L1 stains. Some micro-RNA expression showed over- expression of PD-L1, which resulted in high PD-L1 IHC score. This shows that there may be a case for more bio marker studies to aid in predicting of the response to PD-L1 pathway inhibitors. The rapid molecular testing results were also comparable to next gen sequencing (NGS) in determining the EGFR mutations. Future studies include the training of the PD-L1 AI algorithm for scoring to be used as a diagnostic companion and the use of immune based metrics to study the response and resistance to immunotherapy in non-small cell lung cancer(NSCLC). Conclusion We would like to showcase a combined modality diagnostic biomarker testing system that can allow the clinical decision on the targeted therapy in 24-48 hours. With the approval of Keytruda® (Pembrolizumab) in many advanced cancers, we believe that our approach for NSCLC will provide fast and high quality results for timely treatment of patients.