Profiling Blood from NSCLC Patients for Clinically Actionable Gene Variants Using GeneStrat?

摘要

Standard tumor biopsy mutation testing for patients with non-small cell lung cancer (NSCLC) often have limited sample availability and can increase patient risk due to complications. GeneStrat mutation testing uses a low risk blood draw to provide accurate results and offers a 72 hour turnaround time, supporting critical treatment decisions. This study will report on the performance of GeneStrat?, a blood-based CLIA-certified Laboratory Developed Test (LDT). The test workflow is comprised of three components: (i) a whole-blood collection kit that ships at ambient temperature; (ii) circulating nucleic acids isolated from plasma for analysis using Droplet Digital? PCR (ddPCR), and (iii) a secure laboratory information management system (LIMS) for sample accessioning and test result generation. Metrics associated with the circulating tumor DNA (ctDNA) tests that detect EGFR, KRAS and BRAF mutations for patients with advanced stages of cancer will be presented.