Clinical validation and utility of a liquid biopsy for non-small cell lung carcinoma utilizing CTCs and ctDNA to analyze ALK, ROS and EGFR status.

e19086 Background: A liquid biopsy in addition to clinical utility in a setting of insufficient tissue biopsy and offering better representation of all regions of a tumor to offset tumoral heterogeneity seen in a tissue biopsy, affords a real-time monitoring option to assess biomarker status in patients with non-small cell lung carcinoma. Methods: Biocept, Inc has two key technologies that harness the maximum benefit of a liquid biopsy utilizing both CTCs and ctDNA for biomarker analysis in NSCLC patients in a CLIA laboratory setting. Using a unique microchannel device, CTCs are enriched more than 20,000 fold, stained, enumerated and analyzed for biomarkers using Immunocytochemistry and FISH. After the capture and enumeration of CTCs , ALK and ROS1 gene rearrangements in tumor cells are analyzed using FISH. Additionally, a highly sensitive ctDNA assay, Target-Selector is employed, capable of detecting as low as a single mutant copy in a vast excess of normal sequences. The analytical performance of a T790...