FDA Approves Companion Diagnostic for Amivantamab-vmjw

On May 21, 2021, the U.S. Food and Drug Administration approved the Guardant360^® CDx liquid biopsy test as the first and only companion diagnostic for 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 who harbor the EGFR exon 20 insertion mutation and may benefit from targeted treatment with amivantamab-vmjw after progressing on or after platinum-based chemotherapy.

Read Guardant Health's announcement.

Posted 5/24/2021