Analytical Validation of a Plasma-Based Rapid Liquid Biopsy Assay Using Next-Generation Sequencing

Cell-free total nucleic acid (cfTNA)–based liquid biopsy (LBx) offers a minimally invasive alternative to tissue-based next-generation sequencing (NGS). Most NGS-based LBx assays require several days for results. This study validated a rapid NGS-based LBx assay with a 2-day turnaround time (TAT). Patient plasma samples were used to validate the Oncomine Precision Assay for single-nucleotide variants (SNVs), insertion and deletions (indels), and fusions across 50 genes on the Genexus Sequencer. Manual extraction using the QIAamp cfTNA Kit was performed to optimize fusion detection.