Guardant360 CDx Receives FDA Approval as Companion Diagnostic for Janssen’s RYBREVANT (amivantamab-vmjw) for Use in Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Guardant Health, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Guardant360 CDx liquid biopsy test as the first and only companion diagnostic for Janssen Biotech, Inc.’s (Janssen’s) RYBREVANT (amivantamab-vmjw). The Guardant360 CDx test will be used for tumor mutation profiling, or comprehensive genomic profiling, to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor the EGFR exon 20 insertionmutation andmay benefit from targeted treatment with RYBREVANT after progressing on or after platinum-based chemotherapy.