Concordance Analysis of Liquid Biopsy-based Tumor Variant Detection Between a Centralized Specialty Laboratory and the PGDx elio® plasma focusᵀᴹ Dx Kitted Solution

Liquid biopsy (LBx) is an effective strategy for minimally invasive characterization of solid tumors by detection of tumor-derived cell-free DNA (cfDNA) from blood. This testing modality offers a complementary and/or alternative to tissue biopsy, currently considered standard of care for tumor profiling. Through a next-generation sequencing (NGS) approach, liquid biopsy results can help guide treatment selection and monitor treatment response in advanced cancer patients. National Comprehensive Cancer Network (NCCN®) guidelines currently recommend liquid biopsy molecular profiling via NGS in multiple advanced cancers including NSCLC, breast, colon, rectal, and prostate cancers. PGDx elio plasma Dx (EPF Dx) is an FDA-authorized kitted hybrid-capture NGS LBx assay (DEN230046, August 2024).