FDA Approves Guardant360® CDx Test for NSCLC with KRAS G12C Mutation

On May 28, 2021, the U.S. Food and Drug Administration approved the Guardant360® CDx test 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 KRAS G12C mutation and may benefit from Lumakras™ (sotorasib), an FDA-approved KRASG12C inhibitor developed and manufactured by Amgen.

Read the Guardant Health announcement.

Posted 6/1/2021