FDA approves Guardant360 CDx as companion diagnostic for Eli Lilly and Company’s Inluriyo (imlunestrant) for treatment of ESR1 mutated advanced breast cancer

Guardant Health

29 September 2025 - This marks the second FDA approved indication for Guardant360 CDx as a companion diagnostic in breast cancer treatment.

Guardant Health today announced that the US 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 and Company’s Inluriyo (imlunestrant).

Read Guardant Health press release

Michael Wonder

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Michael Wonder