Guardant Health won Japanese regulatory approval for its Guardant360 CDx as a companion diagnostic to identify ESR1 mutations in breast cancer patients eligible for Eli Lilly’s Inluriyo. The clearance enables plasma‑based genomic testing to guide treatment selection in Japan. The decision expands Guardant’s global CDx footprint and underscores the growing role of liquid biopsies for patient stratification in targeted oncology. Company and regulatory statements provided the approval details.