Guardant’s liquid biopsy approval paves the way for broader adoption of solid tumor profiling

FDA’s approval of a liquid biopsy test from Guardant that produces a comprehensive tumor mutational profile may trigger broader adoption of the tumor screening technology to better match patients to targeted therapies.

FDA approved Guardant360 CDx from Guardant Health Inc. (NASDAQ:GH) on Friday for comprehensive genomic profiling of solid tumors and as a companion diagnostic for EGFR inhibitor Tagrisso osimertinib from AstraZeneca plc (LSE:AZN; NYSE:AZN). The test, which combines liquid biopsy technology with next generation sequencing to detect alterations in over 80 genes, is the first of its kind approved to screen for a large set of tumor-associated mutations. ...