Guardant Health announces FDA approved Guardant360 CDx

Guardant Health (GH) announced that the U.S. Food and Drug Administration, FDA, has approved its Guardant360 CDx as a companion diagnostic to identify advanced breast cancer patients with ESR1 mutations who may benefit from Eli Lilly (LLY) and Company’s Inluriyo. Guardant360 CDx was approved in conjunction with Inluriyo for the treatment of adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy.